Recalls in the last 30 days
540 notices from official recall feeds in the 30 days to Tue 10 Nov. Each links to the agency's own notice; the text is the agency's, shortened where long.
- Consumer products (US) 35
- Food (US) 115
- Medicines (US) 100
- Medical devices (US) 232
- Product safety (UK) 58
Consumer products (US) 35
From the US Consumer Product Safety Commission (US government work (public domain)). Checked 10 Nov, 06:14 UTC.
- Thu 5 NovVanderhall North America Recalls All Model Year 2024-2026 Brawley Electric Recreational Off-road Vehicles Due to Injury and Crash HazardsThe seat belts in Brawley ROVs can permanently lockup in the fully retracted position. If this occurs, consumers would be unable to reset the seat belt and put it on when the vehicle is operating, posing injury and crash hazards to consumers.Consumers should stop using the recalled vehicles immediately and contact an authorized Vanderhall dealer to schedule a free repair. A technician will install an insert into the seat belt guide slot…
- Thu 5 NovBose Recalls Lithium-Ion Battery Packs for S1 Pro and S1 Pro+ Bluetooth Speaker Systems Due to Risk of Injury from Fire and Overheating HazardsThe recalled lithium-ion battery packs can overheat and ignite, posing a risk of injury from fire and overheating hazards.Consumers should remove the recalled battery packs installed in any S1 Pro and S1 Pro+ Portable Bluetooth Speaker Systems and stop using the battery packs immediately. Once the battery pack is remove…
- Thu 5 NovArlopu Recalls Slide Playsets Due to Risk of Serious Injury and Death from Head and Neck Entrapment HazardsThe recalled products contain multiple openings where a child’s torso can fit through the opening, but a child’s head cannot, posing a risk of serious injury and death due to head and neck entrapment hazards. Additionally, the basketball nets on the recalled products with model number KT-CS17 can come unhooked from the rim, forming a loop large enough for a child’s head, posing entanglement and s…Consumers should stop using the Arlopu Slide Playsets immediately and store them away from children. Contact Arlopu for a free repair kit, which includes redesigned panels, basketball hoops and insta…
- Thu 5 NovLittle Giant Recalls Ladders with Rapid Locks Due to Risk of Serious Injury from Fall HazardThe ladders can suddenly retract if the Rapid Locks are not fully engaged, posing a fall hazard to consumers.Consumers should stop using the recalled ladders immediately until they review the information at www.littlegiantladders.com/pages/recalls or via the QR code on the ladder and contact Little Giant fo…
- Thu 5 NovJiastfeng Recalls HAUOMS Eight-drawer Dressers Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violate Mandatory Standard for Clothing Storage UnitsThe recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY Act.Consumers should stop using the recalled dressers immediately if they are not anchored to the wall, place them in an area that children cannot access and contact Jiastfeng for a full refund. Consumer…
- Thu 5 NovGourmia Recalls 9-Slice Digital Air Fryer Ovens Due to Burn HazardThe oven’s doors can unexpectedly close when bumped, posing a burn hazard to consumers retrieving hot food.Consumers should stop using the recalled Ovens immediately and contact Gourmia for a free repair kit by mail. The repair kit will include an added doorstop and instructions on how to install.
- Thu 5 NovC.A.M.P. Recalls Mountain Ice Axes Due to Risk of Serious Injury or Death from Fall HazardA screw on the recalled mountain ice axes can loosen during use, causing the handle or pick to detach, posing a risk of serious injury or death from fall hazard.Consumers should stop using the recalled mountain ice axes immediately and register at https://www.camp-usa.com/x-bolt-recall-102026 to receive a free repair kit. Consumers should have the model and…
- Thu 5 NovKikea Store Recalls X-VESOLJE Nursing Pillows Due to Risk of Serious Injury or Death from Suffocation; Violate Mandatory Standards for Nursing PillowsThe recalled nursing pillows violate the mandatory safety standards for nursing pillows because they can obstruct an infant’s breathing, posing a serious risk of injury or death from suffocation.Consumers should stop using the recalled nursing pillows immediately and contact Kikea Store for a full refund. Consumers will be asked to cut the pillow in half after confirming the recalled pillow…
- Thu 5 NovBaby Brezza Enterprises Recalls SuperFast Sterilizer Dryers Due to Overheating and Burn HazardsThe recalled sterilizer dryers can overheat when plugged in and operating, posing a risk of injury from a burn hazard if the surface is handled.Consumers should stop using the recalled sterilizer dryers immediately and contact Baby Brezza Enterprises for a free replacement sterilizer dryer, including shipping at no cost to the consumer. Cons…
- Thu 5 NovSanven Technology Recalls Vevor BMX Bicycles Due to Risk of Serious Injury or Death from Crash Hazard; Violate Federal Requirements for BicyclesThe bicycles violate the mandatory safety regulation for bicycles, because they are not equipped with a chain guard. Loose clothing can get entrapped in the chain drive, posing a risk of serious injury or deadly crash hazard. In addition, the bicycles do not comply with the labeling requirements.Consumers should stop using the BMX bicycles immediately and contact Sanven Technology for a free repair kit. Consumers will be shipped free chain guards, with detailed installation tutorials and pro…
- Thu 5 NovU.S. Titan Recalls X-Pro Youth All-Terrain Vehicles (ATVs) Due to Risk of Serious Injury or Death from Crash Hazard; Violate Mandatory Standard for ATVsThe recalled ATVs violate the mandatory ATV safety standard because the speed-adjusting module included with the vehicle allows for the ATV’s speed to be adjusted in excess of the maximum speed for vehicles intended for children 6 years old and older, posing a risk of serious injury or death from a crash.Consumers should stop using the speed-adjusting module included with the vehicle immediately and contact X-PRO for a $100 refund. Consumers can continue using the vehicle without the module. Consumer…
- Thu 5 NovMagnetopia Recalls Magnetic Building Cubes and Blocks Due to Risk of Serious Injury or Death from Magnet Ingestion HazardThe recalled magnetic building cubes contain magnets that can become loose if the cubes break or open, posing a magnet ingestion hazard to children. When high-powered magnets are swallowed, the ingested magnets can attract each other, or other metal objects, and become lodged in the digestive system. This can result in perforations, twisting, and/or blockage of the intestines, blood poisoning and…Consumers should stop using the recalled magnetic building cubes immediately and contact Magnetopia for a full refund. Consumers will be provided with a pre-paid label to return the recalled magnetic…
- Thu 29 OctFashion Brand Apparel Recalls QZH.DUAO Pajama Sets Due to Risk of Serious Injury or Death from Burn Hazard; Violate Mandatory Standards for Children’s SleepwearThe recalled children’s pajama sets violate the mandatory safety standards for children’s sleepwear, posing a risk of serious burn injuries.Consumers should stop using the recalled pajama sets immediately and contact Fashion Brand Apparel for a full refund. Consumers will be asked to cut the pajamas in half and email a photo of the destr…
- Thu 29 OctPILLANI Recalls Nursing Pillows Due to Risk of Serious Injury or Death from Suffocation; Violate Mandatory Standards for Nursing PillowsThe recalled nursing pillows violate the mandatory safety standards for nursing pillows because they can obstruct an infant’s breathing, posing a serious risk of injury or death from suffocation.Consumers should stop using the nursing pillows immediately and contact PILLANI for a full refund. Consumers will be asked to send a photo of the product and be provided with disposal instructions. C…
- Thu 29 OctSOOWERY Recalls 8-Drawer Fabric Dressers Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violate Mandatory Standard for Clothing Storage UnitsThe recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY Act.Consumers should stop using the recalled dressers immediately if they are not anchored to the wall, place them in an area that children cannot access and contact SOOWERY for a full refund. Consumers…
- Thu 29 OctWhatever Works Recalls Microwave Grills Due to Risk of Serious Injury or Death from Fire HazardThe recalled grills can overheat and ignite, posing a risk of serious injury or death from fire hazard.Consumers should stop using the recalled grills immediately and contact Whatever Works for a full refund. Consumers will be asked to write in permanent marker “Recalled” on the grill and send a photo…
- Thu 29 OctNTI and HTP Brand Gas Boilers Recalled Due to Risk of Serious Injury or Death from Fire, Carbon Monoxide (CO) Poisoning and Impact Hazards; Manufactured by Ariston, formerly NTI BoilersThe condensate dish inside the boiler can crack during a delayed ignition, allowing unburned gas to build up inside the sealed cabinet. If the gas ignites, the front cover can suddenly detach, posing a risk of serious injury or death from fire, carbon monoxide (CO) poisoning, and impact hazards.Consumers should stop using the recalled boilers immediately and contact Ariston to schedule a free repair by a certified technician. Consumers who must continue using the boiler while awaiting repai…
- Thu 29 OctDREO Recalls DR-HSH015 Space Heaters Due to Fire and Burn HazardsThe recalled space heaters can overheat and ignite, posing fire and burn hazards.Consumers should stop using the recalled space heaters immediately and contact DREO for a free replacement space heater. Consumers will be asked to unplug the space heater, destroy it by cutting the…
- Thu 29 OctBodum USA Recalls 5.9 Million French Press Coffee Makers with Replaceable Glass Carafes Due to Risk of Serious Burn InjuryThe carafe can unexpectedly break during use if the glass carafe is damaged or cracked, including by use of a metal spoon to stir the coffee, posing a risk of serious burn injuries.Consumers should stop using metal spoons or utensils to stir coffee in the glass carafe immediately and contact Bodum to receive a plastic Bodum stirring spoon and warning label. The label reminds co…
- Thu 29 OctHAIARA Power Banks Recalled Due to Risk of Serious Injury or Death from Fire and Burn Hazards; Sold on Amazon.com by MitrytechThe power bank’s lithium battery can explode and ignite, posing fire and burn hazards to consumers.Consumers should stop using the recalled power banks immediately. Consumers who purchased their power banks on Amazon.com from Mitrytech should contact Mitrytech for instructions on how to receive a…
- Thu 29 OctRootStim Recalls Minoxidil Hair Regrowth Treatment Bottles Due to Risk of Serious Injury or Death from Child Poisoning; Violate Mandatory Standard for Child-Resistant PackagingThe recalled hair regrowth products contain minoxidil, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The bottle is not child-resistant, posing a risk of serious injury or death from poisoning if the contents are ingested by young children.Consumers should secure the recalled products out of sight and reach of children immediately and contact RootStim for instructions on receiving a replacement product. Consumers will be asked to write…
- Thu 29 OctYinklev Recalls Jocoevol 6-Drawer Dressers Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violate Mandatory Standard for Clothing Storage UnitsThe recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY Act.Consumers should stop using the recalled dressers immediately if they are not anchored to the wall, place them in an area that children cannot access and contact Yinklev for a full refund. Consumers…
- Thu 29 OctHarkla Recalls Children’s Sensory Swings Due to Risk of Serious Injury from Fall HazardThe recalled swings’ ceiling hook can separate from its plate, posing a risk of serious injury from a fall hazard.
- Thu 29 OctLongjili Trading Recalls Pamag Pieeoo Mattresses Due to Risk of Serious Injury or Death from Fire Hazard; Violate Mandatory Standard for Mattress FlammabilityThe recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.Consumers should stop using the recalled mattresses immediately and contact Longjili Trading for a full refund. Consumers will be asked to destroy the mattress by writing in permanent marker “RECALLE…
- Thu 22 OctFoShanShiNanHaiQuNuoAiTongZhuangShangHang Recalls CIYTI Light-Up Princess Costumes Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for ToysThe costumes violate the mandatory safety standard for toys because the button cell batteries can be accessed easily by children, posing a deadly ingestion hazard. If button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, including internal chemical burns, and death.Consumers should take the princess costumes away from children immediately, stop using them and contact FoShanShiNanHaiQuNuoAiTongZhuangShangHang for a full refund. Consumers will be asked to write "…
- Thu 22 OctVQQQ Gas Patio Heaters Recalled Due to Risk of Serious Injury or Death from Fire and Burn HazardsComponents on the recalled patio heaters can malfunction, causing gas to be released, posing a risk of serious injury or death from fire and burn hazards.Consumers should stop using the recalled patio heaters immediately, shut the valve at the portable gas source, disconnect the gas hose and contact VQQQ for a full refund. Consumers will be asked to w…
- Thu 22 OctCostway Recalls Convertible High Chairs Due to Risk of Serious Injury or Death from Entrapment and Fall Hazards; Violate Mandatory Standard for High ChairsThe convertible high chairs violate the mandatory safety standard for high chairs because they do not contain a passive restraint system and a child can slip through the opening between the feeding tray and seat and become entrapped or fall, posing a risk of serious injury or death.Consumers should immediately stop using the recalled high chairs and contact Costway for a free replacement high chair. Consumers will be asked to provide a receipt or a photo of the product and will…
- Thu 22 OctLithonia Lighting Recalls RSX Luminaires with Adjustable Tilt Arm Mountings Due to Risk of Serious Injury from Impact HazardThe knuckle of the recalled adjustable tilt arm mountings can fail, allowing the luminaire to fall from the mounting arm, posing a risk of serious injury due to impact hazard.Consumers should keep clear of the area directly beneath the Luminaire and contact Lithonia Lighting to schedule a free repair. Lithonia Lighting will arrange for a qualified professional to replace…
- Thu 22 OctBAMAMON Recalls LED Projecting Finger Light Toys Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for ToysNone reported.Consumers should stop using the toys immediately and contact Bamamon. Consumers will be asked to email a photograph showing the product being properly disposed of in the trash to bamamonproductrecall…
- Thu 15 Oct3M Company Recalls Scotch™ Thermal Laminators Due to Risk of Serious Injury or Death from Fire HazardThe recalled thermal laminators can overheat, posing a fire hazard.Consumers should stop using and unplug the recalled thermal laminators immediately and contact 3M Company to receive a full refund. Consumers will be asked to fill out the online recall registration…
- Thu 15 OctHatsanUSA Recalls Blitz Air Rifles Due to Risk of Serious Injury or Death from Projectile HazardThe recalled air rifles can fire unexpectedly when releasing the bolt before the air rifle is fully cocked, posing a risk of serious injury or death from projectile hazard.Consumers should stop using the recalled air rifles immediately, make sure they are unloaded and contact HatsanUSA for a free trigger assembly replacement which will be mailed along with instructions…
- Thu 15 OctLoving Thyself Rocks Recalls Crystal Glass Cups Due to Risk of Serious Injury from Ingestion and Laceration HazardsGlass can break inside the recalled cups while in use, posing a risk of serious injury from ingestion and laceration hazards.Consumers should stop using the recalled crystal cup immediately and register at http://www.lovingthyselfrocks.com/recall to receive a full refund in the form of original payment. Consumer will be as…
- Thu 15 OctPapablic, of USA Recalls Convertible Bedside Sleepers Due to Risk of Serious Injury or Death from Entrapment, Suffocation and Fall Hazards; Violate Mandatory Standard for Play YardsThe bedside sleepers with play yard extensions violate the mandatory safety standard for play yards because the mattress can become displaced, causing a baby to become entrapped between the sleeping pad and bottom posing a deadly suffocation hazard. In addition, the latching and locking mechanism can fail, causing the product to collapse, posing a risk of serious injury or deadly entrapment and f…Consumers should stop using the convertible bedside sleeper immediately and contact Papablic for a refund. Consumers will be asked to disassemble the product, cut the mattress and fabric components i…
- Thu 15 OctPrimark Recalls 101 Dalmatians Faux Leather Children’s Coin Purses Due to Phthalate Levels and Risk of IngestionThe coin purses contain higher phthalate concentration levels. Phthalates can be harmful if young children are exposed to sufficient amounts, including through ingestion, and certain phthalates have been associated with adverse health effects, particularly effects on development and the hormone system.Consumers should stop using the coin purses immediately, keep them away from children and return them to a Primark store for a full refund in the original form of payment.
- Thu 15 OctusOpal Recalls Xalirium Portable Bed Rails Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed RailsThe recalled bed rails violate the mandatory standard for adult portable bed rails because when the bed rails are attached to a bed, users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation. The bed rails do not meet structural stability or retention strap requirements, posing a fall h…Consumers should stop using the recalled adult portable bed rails immediately and contact usOpal for a full refund. Consumers will be asked to cut the black storage bag and straps and to cut the foam…
All consumer products recalls on the Consumer Product Safety Commission site
Food (US) 115
From the US Food and Drug Administration (openFDA, CC0 1.0). Checked 10 Nov, 06:14 UTC. Dates are the FDA weekly enforcement report the recall appeared in.
- Wed 4 NovPink House Alchemy, LLC: Blue Bottle Coffee 4oz Sweet Blossom Simple Syrup in a glass boston round bottle with metal and plastisol cap. The label reads in part as "***BLUE BOTTLE COFFEE SWEET BLOSSOM…Potential contamination with mold (Aspergillus niger)Class II · Ongoing
- Wed 4 NovFORTUNA MARKETING, INC: ZestiGreens Broccoli Seeds for Sprouting & Microgreens; 8 OZ; Heirloom Broccoli Seeds. SKU: X004IOM4AJ ZestiGreens Broccoli Seeds for Sprouting & Microgreens; 16 OZ; Heirloom…Broccoli seeds potentially contaminated with SalmonellaClass I · Ongoing
- Wed 4 NovEDEN BROTHERS: EDEN BROTHERS Broccoli Seeds - Calabrese. Sold in packets, Net Wt. 1oz pouches, UPC SVBRO111 -qb2 & 1 Pound pouches UPC SVBRO111 -qb4.SalmonellaClass I · Ongoing
- Wed 4 NovProsperity Organic Foods Inc: Miyoko's Creamery European Style Salted Plant Milk Butter, Net Wt. 8 OZ (227G). UPC 857554005773. Distributed By: Prosperity Organic Foods, Inc. Boise, Idaho 83702. Prod…Product recalled due to yeast, mold, and E. coli.Class II · Ongoing
- Wed 4 NovOliva on Main: Riad's Oliva to Go Baba Ghanoujcontains undeclared sesameClass I · Ongoing
- Wed 4 NovOliva on Main: Riad's Oliva to Go Spicy Baba Ghanoujcontains undeclared sesameClass I · Ongoing
- Wed 4 NovOliva on Main: Riad's Oliva to Go Hummuscontains undeclared sesameClass I · Ongoing
- Wed 4 NovSunny Sky Products, LLC: Sunny Sky Non-Dairy French Vanilla Creamer, 96oz , bag in box, 3 per case, refrigerate after opening.Product sterility was potentially compromised.Class II · Ongoing
- Wed 4 NovGF Blends Inc: Gluten Free Truly AIP All Purpose Baking Mix Flour 15.3 ozProducts are recalled due to potential undeclared wheat glutenClass I · Ongoing
- Wed 4 NovGF Blends Inc: Gluten Free Truly AIP Rustic Bread Mix, 14 ozProducts are recalled due to potential undeclared wheat glutenClass I · Ongoing
- Wed 4 NovGF Blends Inc: Gluten Free EAT G.A.N.G.S.T.E.R Pizza Crust and Flat Bread Mix, 5.8oz (165g) & 3.98 lbs.Products are recalled due to potential undeclared wheat glutenClass I · Ongoing
- Wed 4 NovJXK Enterprises, Inc.: Boner Bears CHOCOLATE, 3 DOSES PER BAR, NET WT. 22g, MALE ENHANCEMENT, DOSAGE: Consume 1 piece at least 1 hour prior to activity. Do not exceed 1 piece in any 48 hour period. S…JXK Enterprises, Inc is voluntarily recalling Boner Bears Chocolate, Lot #BB21125, after being notified that FDA laboratory analysis confirmed the presence of sildenafil, an active ingredient in the FDA-approved prescription drug Viagra, which is not declared on the product label.Class I · Ongoing
- Wed 28 OctGearharts Fine Chocolates, Inc.: GEARHARTS FINE CHOCOLATES Net Wt. 4oz UPC 8 98111 00205 7; Net Wt. 8oz UPC 8 98111 00206; Gearharts Fine Chocolates 243B Ridge McIntire Rd, Charlottesville, VA 22902Foreign Object - Broken glass was found in a piece of finished product.Class II · Ongoing
- Wed 28 OctSempio Food Services, Inc: Sempio Yellow Peach; Product of Korea; NET WT. 14.10 oz. UPC: 8801005320825elevated level of lead in canned peachesClass II · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Natural Sesame Seeds; packed in a clear plastic bag. 1lb, 5lb, 50lb unit size. No UPCvarious undeclared allergen ingredients (Sesame)Class III · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Black Sesame Seeds; packed in a clear plastic bag. 1lb, 5lb, 50lb unit size. No UPCundeclared allergen ingredient (Sesame)Class III · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Hulled Sesame Seeds; packed in a clear plastic bag. 1lb, 5lb, 50lb unit size. No UPCundeclared allergen ingredient (Sesame)Class III · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Almonds in Shell; packed in a clear plastic bag. 1lb, 5lb, 50lb unit size. No UPCundeclared allergen ingredient (Almond)Class III · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Chocolate Covered Almonds; packed in a clear plastic bag. 1lb, 5lb, 50lb unit size. No UPCundeclared allergen ingredient (Almond)Class III · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Roasted Whole Almonds; packed in a clear plastic bag. 1lb, 5lb, 25lb unit size. No UPCundeclared allergen ingredient (Almond)Class III · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Sliced Almonds; packed in a clear plastic bag. 1lb, 5lb, 25lb unit size. No UPCundeclared allergen ingredient (Almond)Class III · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Hazelnuts in Shell; packed in a clear plastic bag. 1lb, 5lb, 50lb unit size. No UPCundeclared allergen ingredient (Hazelnut)Class III · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Dried Cod; packed in a clear plastic bag. 1lb, 5lb, 50lb unit size. No UPCundeclared allergen ingredient (Fish)Class III · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Butter Toffee Peanuts; packed in a clear plastic bag. 1lb, 5lb, 50lb unit size. No UPCundeclared allergen ingredient (Peanuts, Milk)Class III · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Raw In-Shell Peanuts; packed in a clear plastic 1lb, 5lb, 50lb unit sizes. Raw Spanish Peanuts; sold by weight (bulk) Raw shelled Peanuts; packed in a clear plastic 1lb,…undeclared allergen ingredient (Peanuts)Class III · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Dried Whole Shrimp; packed in a clear plastic 1lb, 5lb, 30lb unit sizes. No UPCundeclared allergen ingredient (shrimp)Class III · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Ground Shrimp; packed in a clear plastic 1lb, 5lb, 25-50lb unit sizes. No UPCundeclared allergen ingredient (shrimp)Class III · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Whole Pitted Dried Apricots; packed in a clear plastic 1lb, 5lb, 28lb unit sizes. no UPCundeclared allergen ingredient (Sulfites)Class II · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Churro Mix; packed in a clear plastic 1lb, 5lb, 50lb unit sizes. no UPCundeclared allergen ingredient (Egg, Wheat)Class II · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Dried Peaches; packed in a clear plastic 1lb, 5lb, 22-25lb unit sizes. No UPCundeclared allergen ingredient (Sulfites)Class II · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Soybeans; packed in a clear plastic 1lb, 5lb, 50lb unit sizes. No UPCundeclared allergen ingredient (Soy)Class III · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Fritura mixed dry fruit; packed in a clear plastic 1lb, 5lb, 25lb unit sizes. no UPCundeclared allergen ingredient (Wheat, Yellow #5, Yellow #6)Class II · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Fritura Lagrimita / Teardrop Wheat Snack; packed in a clear plastic 1lb, 5lb, 44lb unit sizes.undeclared allergen ingredient (Wheat, Yellow #6, Soy)Class II · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Fritura Rueda / Wheat Wheel Snack; packed in a clear plastic 2lb, 5lb, 33lb unit sizes. no UPCundeclared allergen ingredient (Wheat, Yellow#5, Yellow #6,)Class II · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Fritura Rueda Papa / Potato Wheel Snack; packed in a clear plastic 1lb, 5lb, 33lb unit sizes. No UPCundeclared allergen ingredient (Wheat)Class I · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Dried Fruit Mix; packed in a clear plastic 1lb, 5lb, 25lb unit sizes.undeclared allergen ingredient (Sulfites, Yellow#6)Class II · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Jovy Gummy Peach Rings; packed in a clear plastic 1lb unit sizes. UPC: 712199083404undeclared allergen ingredient (Red#40, Yellow#5, Yellow#6)Class II · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Apple Rings; packed in 1lb, 5lb, and 2lb unit sizes. Product code: APLC-R01-22undeclared sulfitesClass II · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Jovy Watermelon Gummy Rings; packed in a clear plastic 1lb unit sizes. UPC 712199083510undeclared allergen ingredient (Red#40)Class III · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Jovy Gummy Bears Neon; packed in 1lb plastic units. UPC 712199083558undeclared allergen ingredient (Red#40, Yellow#5, Yellow#6, Blue#1)Class II · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Jovy Gummy Bears Regular; packed in a clear plastic 1lb unit sizes. UPC: UPC 712199085156undeclared allergen ingredient (Red#40, Yellow#5, Yellow#6, Blue#1)Class II · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Jovy Gummy Worms Neon; packaged in 1lb plastic units. UPC 712199083411undeclared allergen ingredient (Red#40, Yellow#5, Yellow#6, Blue#1)Class II · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Jovy Gummy Worms (Regular); packaged in 1lb plastic units. UPC: 712199083398undeclared allergen ingredient (Red#40, Yellow#5, Yellow#6, Blue#1)Class II · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: All-Purpose Flour; packaged in 1lb, 5lb, 50lb clear plastic units. No UPCundeclared allergen ingredient (Wheat)Class II · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Almond Flour; packaged in 1lb, 5lb, 50lb clear plastic units. No UPCundeclared allergen ingredient (Almond)Class III · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Harina de Trigo; Whole Wheat Flour; packed in a clear plastic bag. 1lb, 5lb, 50lb unit size. No UPCundeclared allergen ingredient (Wheat)Class III · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Honey Nut Granolaundeclared allergen ingredient (Almond, Cashew)Class II · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Horchata Drink Mix; packaged in 1lb, 5lb, 50lb clear plastic units. No UPCundeclared allergen ingredient (Milk)Class I · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Dried Kiwi Slices; packaged in 1lb, 5lb, 44lb clear plastic units. No UPCundeclared allergen ingredient (Sulfites, Yellow#5, Blue#1)Class II · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Dried Mango Slices; packaged in 1lb, 5lb, 44lb clear plastic units. No UPCundeclared allergen ingredient (Sulfites, Yellow#6)Class II · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Air-Dried Apple Rings; packaged in 1lb, 5lb, 22lb clear plastic units. No UPCundeclared allergen ingredient (Sulfites)Class II · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Roasted & Salted Mixed Nuts; packaged in 1lb, 5lb, 25lb clear plastic units. Roasted & Unsalted Mixed Nuts; packaged in 1lb, 5lb, 25lb clear plastic units. No UPCundeclared allergen ingredient (Cashew, Almond, Brazil Nut, Hazelnut, Pecan)Class II · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Special Red Almond Mole Powder; packaged in 1lb, 5lb, 11lb clear plastic units. No UPCundeclared allergen ingredient (Sesame, Peanuts, Wheat, Soy, Almonds, Walnuts, Yellow#5, Yellow#6, Red#40, Blue#2)Class I · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Homestyle Poblano Mole; packaged in 1lb, 5lb, 22lb clear plastic units. No UPCundeclared allergen ingredient (Sesame, Peanuts, Wheat, Soy, Sulfites)Class I · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Walnuts in Shell; packaged in 1lb, 5lb, 50lb clear plastic units. No UPCundeclared allergen ingredient (Walnuts)Class III · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Walnut halves; packaged in 1lb, 5lb, 22-25lb clear plastic units. No UPCundeclared allergen ingredient (Walnuts)Class III · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Pecans in Shell; packaged in 1lb, 5lb, 50lb clear plastic units. No UPCundeclared allergen ingredient (Pecans)Class III · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Bread Crumbs; packaged in 1lb, 5lb, 50lb clear plastic units. No UPCundeclared allergen ingredient (Milk, Wheat, Sesame, Soy)Class I · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Dried Diced Papaya; packaged in 1lb, 5lb, 44lb clear plastic units. No UPCundeclared allergen ingredient (Yellow#6, Sulfites)Class II · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Dried Papaya Spears; packaged in 1lb, 5lb, 44lb clear plastic units. No UPCundeclared allergen ingredient (Yellow#6, Sulfites)Class II · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Dried Pears; packaged in 1lb, 5lb, 25lb clear plastic units. No UPCundeclared allergen ingredient (Sulfites)Class II · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Dried Diced Pineapple; packaged in 1lb, 5lb, 44lb clear plastic units. No UPCundeclared allergen ingredient (Sulfites)Class II · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Dried Pineapple Rings; packaged in 1lb, 5lb, 44lb clear plastic units. No UPCundeclared allergen ingredient (Sulfites)Class II · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Shelled White Pine Nuts; packaged in 1lb, 5lb, 25-55lb clear plastic units. No UPCundeclared allergen ingredient (Pine Nuts)Class III · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Raw Shelled Pistachios; packaged in 1lb, 5lb, 25-30lb clear plastic units. No UPCundeclared allergen ingredient (Pistachios)Class III · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Wheat Bran; packaged in 1lb, 5lb, 50lb clear plastic units. No UPCundeclared allergen ingredient (Wheat)Class III · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Textured Soy Protein; packaged in 1lb, 5lb, 33lb clear plastic units. No UPCundeclared allergen ingredient (Soy)Class III · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Whole Wheat; packaged in 1lb, 5lb, 50lb clear plastic units. No UPCundeclared allergen ingredient (Wheat)Class III · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Tropical Trail Mix; packaged in 1lb, 5lb, 25lb clear plastic units. No UPCundeclared allergen ingredient (Peanuts, Almonds, Sulfites, Yellow#6)Class II · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Milk Chocolate Covered Raisins; packaged in 1lb, 5lb, 20lb clear plastic units. No UPCundeclared allergen ingredient (Milk, Soy)Class II · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: 10X10 Wheat Snack; packaged in 2lb, 5lb, 33lb clear plastic units. No UPCundeclared allergen ingredient (Wheat)Class III · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: 4X6 Wheat Snack; packaged in 1lb, 5lb, 33lb clear plastic units. 4X8 Wheat Snack; packaged in 1lb, 5lb, 33lb clear plastic units. No UPCundeclared allergen ingredient (Wheat)Class III · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Tube Shaped Wheat Snack; packaged in 1lb, 5lb, 33lb clear plastic units. No UPCundeclared allergen ingredient (Wheat)Class III · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Whole wheat flour; packaged in 1lb, 5lb, 50lb clear plastic units. No UPCundeclared allergen ingredient (Wheat)Class III · Ongoing
- Wed 28 OctEl Ruisenor De Mexico, Inc.: Wheat Germ; packaged in 1lb, 5lb, 50lb clear plastic units. No UPCundeclared allergen ingredient (Wheat)Class III · Ongoing
- Wed 28 OctTrader Joe's Company: Trader Joe's Crispy Rice Milk Chocolate Bar; Imported from Belgium, 3- 1.75 oz bars. Package contains 3 individually wrapped bars packaged together within one outer label. UPC:…Undeclared wheat. Product outer label incorrect; contains wrong allergen ingredients.Class II · Ongoing
- Wed 28 OctVoila Juice Company: Voila! juice 100% SQUEEZED ORANGE VOILA! OAKLAND, CA 94601 16 OZ: UPC 701725001074 32 OZ: UPC 701725001081 64 OZ: UPC 701725001098 128 OZ: UPC 701725001104Product not processed to achieve 5-log pathogen reduction.Class II · Ongoing
- Wed 28 OctVoila Juice Company: Andronico's COMMUNITY MARKETS 100% SQUEEZED ORANGE ANDROINCO'S COMMUNITY MARKETS SAN LEANDRO, CA 94577 16 OZ: UPC 675643050967 32 OZ: UPC 675643050974 64 OZ: UPC 675643050981Product not processed to achieve 5-log pathogen reduction.Class II · Ongoing
- Wed 28 OctPacific Coast Producers: Great Value Fruit Cocktail in Fruit Juice from Concentrate NET WT 15 OZ (425g) DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716 UPC: 078742369570Potential contamination with elevated levels of lead.Class II · Ongoing
- Wed 28 OctPacific Health Sciences Llc: Babies' Magic Tea; Baby Sleep Gripe Water; Dietary Supplement; Net Wt. 4 OZ; Age 2eeks+ "No Alcohol, Dairy, Wheat, Soy And Animal Testing" UPC: 850302008183Adulterated (elevated levels of alcohol) infant dietary supplementClass II · Ongoing
- Wed 28 OctWalker Foods, Inc: Marca El Pato Salsa para Enchiladas; 28 ounce Can: 0 72360 00208 6 Case: 0 72360 20612 5Undeclared salt, garlic, and onionsClass II · Ongoing
- Wed 28 OctEVEXIAS HEALTH SOLUTION: Evexias Health Solutions Amino Ultra, 90-capsules, dietary supplement in white plastic bottles with blue/green/white labelingThe product is mislabeled and fails to declare fish oil.Class II · Ongoing
- Wed 28 OctWild West Seed Inc: Wild West Seeds Broccoli Seeds Green Sprouting Calabrese lot #4105. Net Wt. 50lb. Wild West Seeds Broccoli Waltham29 Seeds lot #4475 (this lot was sent to only one consignee). Net…SalmonellaClass I · Ongoing
- Wed 28 OctPRIMAL SUPPLEMENTS GROUP LLC: PRIMAL HERBS, VOLUME, HERBAL SUPPLEMENT, Net Wt. 8.5 oz, 30 servingsFDA laboratory analysis confirmed that Primal Herbs Volume contains sildenafil not listed on the product label.Class I · Ongoing
- Wed 28 OctGardeners Basics: Gardners Basics brand Waltham 29 Broccoli Sprouting Seeds packaged in a white and green resealable pouch, net weight 1 pound (454 g), with UPC: 848137042889. The bag is marked with…SalmonellaClass I · Ongoing
- Wed 28 OctEAK Distribution LLC: Heirloom Homegrown Green Sprouting Calabrese Broccoli Sprouts Seed. Net wt. 8oz ASIN #B09P49WHHP, UPC 8 50056 62744 3. EAK Distribution LLC 5830 E. 2nd St. PMB 91446 Casper, WY…Salmonella.Class I · Ongoing
- Wed 21 OctMade Fresh Salads Inc: Made Fresh brand Black Bean and Corn Salad; 5lb white plastic tubProducts may be contaminated with Listeria monocytogenes.Class I · Ongoing
- Wed 21 OctHolsum De Puerto Rico, Inc.: Holsum Spinach Flour Tortillas Large, 8 count (20 oz.) UPC: 810023430629Undeclared colors (FD&C Blue No. 1 and FD&C Yellow No. 5)Class II · Ongoing
- Wed 21 OctSaratoga Potato Chips LLC: J. HIGGS Loaded Bacon & Cheddar Potato Chips, NET WT 7.75 OZ (219.7g) bag, UPC 051933316454. Sold as 13 (7.75oz) bags per case.Undeclared soy.Class II · Ongoing
- Wed 21 OctDARING FOODS INC: Made From Plants; Daring; Plant Steak Bites; Ready in 4 Mins Microwaveable Pouch; UPC: 86001124319defective packaging; packaging can rupture/explode during cooking.Class II · Ongoing
- Wed 21 OctDEANO'S PASTA: Deano's Pasta; Pear and Pecorino Triangoli Ravioli, 1lb.; Ingredients: Dough: Semolina (Wheat, Niacin, Thiamine, Mononitrate, Riboflavin, Folic Acid), Water, Fresh Eggs, Salt. Filling:…Undeclared LobsterClass I · Ongoing
- Wed 21 OctStewart's Shops Corp.: Stewarts Shops Vanilla chocolate Strawberry Ice Cream 1/2 gallon (1.89 L), UPC: 0 82086 44377 3Foreign object: May contain pieces of metalClass II · Ongoing
- Wed 21 OctStewart's Shops Corp.: Stewarts Shops Vanilla Heavenly Medley 1/2 Gallon (1.89 L), UPC Codes: 0 82086 44371 1Foreign object: May contain pieces of metalClass II · Ongoing
- Wed 21 OctRefresco Beverages US Inc: Pur Aqua Sparkling Frost Cherry Limeade 17 oz., UPC: 4099100167023May contain undeclared aspartame.Class III · Ongoing
- Wed 14 OctLEASA Industries Co., Inc.: LEASA Living Alfalfa Sprouts; packaged in plastic clamshell containers; KEEP REFRIGERATED; NET WT. 4 OZ. (113g); Grown & Packaged by: LEASA Industries Co., Inc., Mami FL 3…Seeds may have been contaminated with E. coliClass I · Ongoing
- Wed 14 OctLEASA Industries Co., Inc.: LEASA Alfalfa Sprouts; packaged in plastic clamshell containers; KEEP REFRIGERATED; NET WT. 6 OZ. (170g); Grown & Packaged by: LEASA Industries Co., Inc., Mami FL 33147; P…Seeds may have been contaminated with E.coliClass I · Ongoing
- Wed 14 OctG L Mezzetta Inc: Mezzetta GOLDEN GREEK PEPERONCINI MEDIUM HEAT 32 FL OZ G.L. MEZZETTA, INC., AMERICAN CANYON, NAPA VALLEY, CA 94503 PRODUCT OF GREECE UPC: 073214003280Potential contamination with foreign objects: mice.Class II · Ongoing
- Wed 14 OctWinCo Foods LLC: WinCo Foods Salsa Bean Dip Express Tray is packaged in a foil bottom container with clear plastic lid. Net Wt. 54oz. UPC 2 67173 510983. WinCo Foods Salsa Bean Dip Tray 16inch (sold…Bean Dip Trays contains recalled Peperoncini (pepper) which was recalled due to pest issue.Class II · Completed
- Wed 14 OctPepsico Inc: 28 oz. Gatorade Lemon Lime, Gatorade Lemon Lime Zero, Gatorade Orange, and Gatorade Orange Zero.Undeclared Yellow No. 6 and/or Yellow No. 5Class II · Ongoing
- Wed 14 OctThe Better Bakehouse Snack Company: Donutful Chocolate Dipped Vanilla Cake Donuts - 7.05oz/10ct.Case Configuration 5 count carton, 6 cartons per case. UPC 850041392103. Paperboard carton containing 5…Undeclared Milk.Class I · Ongoing
- Wed 14 OctFRESHPOINT CENTRAL FLORIDA, INC.: Cranberry Chicken Salad Wedge 4.5 oz package in Wedge plastic and clear container with a plastic film sealing the top.The chicken salad sandwich has an improperly declared allergen (egg). While egg is included in the ingredients list on the package label, it is not included in the allergen Contains statement.Class II · Ongoing
- Wed 14 OctBerlin Seeds: Berlin Seeds Alfalfa Sprouting Seeds, packaged in 1/4 lb., 1/2 lb., 1 lb., and 5 lb. resealable bags and 50 lb. woven poly bagsProduct contains alfalfa seed recalled by the supplier due to potential E. coli and/or Salmonella contamination.Class I · Ongoing
- Wed 14 OctGIAS FOOD INC.: Lemon Alfredo Fettuccine packed in a yellow plastic sealed bag with pink and black lettering; label reads in part as "bettergoods Lemon Alfredo Fettuccine, MADE IN ITALY, NET WT 22 OZ…Contamination with Listeria monocytogenesClass I · Ongoing
- Wed 14 OctQUESO PALMITA GP LLC: QUESO PALMITA. Generic Name: Pastel de Queso (Cheese Pie). Intended use: Human consumption. Condition: Frozen. Shelf life or expected life: 90 days. Type of packaging: Vacuum, r…Undeclared milk, cheese declaredClass II · Ongoing
- Wed 14 OctA&P CREATIONS: X10 Natural Enhancement Supplement, 0.5 fl oz/sachet (15 mL), 7 sachets/box, UPC: 7708075247094, Manufactured by FutuPro S.A.S., Colombian Industry; Distributed by Natur Fuel, 2725 Arm…Product contains undeclared Sildenafil and Tadalafil.Class I · Ongoing
- Wed 14 OctA&P CREATIONS: biQ-FEL, 16.9 fl oz (500 mL), 17 servings per bottle, Manufactured by ALMENAT SAS AV 39 OESTE No 10 OESTE-18 CALI VALLE INDUSTRIA COLOMBIANA; Distributed by: BiofelProduct contains undeclared Sildenafil and Tadalafil.Class I · Ongoing
- Wed 14 OctSWEET SENSI: Sweet Sensi Elevated Edibles Hybrid Gum Drops - Passion Guava Kush 140mg THC. Product is packaged in sealable & flexible gold, purple and black metallic plastic mylar pouch and is sold i…Staphylococcus aureus detected in product.Class II · Ongoing
- Wed 14 OctSaint Francis Apizza LLC: Saint Francis Apizza Frozen Pepperoni Pizza, Net Weight: 17 oz. (482g), packaged individually in vacuum-sealed plastic, UPC: 6 66186 27762 1Undeclared soy allergen: soybean oil and soy lecithinClass II · Ongoing
- Wed 14 OctSaint Francis Apizza LLC: Saint Francis Apizza Frozen Cheese Pizza, Net Weight: 17 oz. (482g), packaged individually in vacuum-sealed plastic, UPC: 6 66186 27759 1Undeclared soy allergen: soybean oil and soy lecithinClass II · Ongoing
- Wed 14 OctSaint Francis Apizza LLC: Saint Francis Apizza Frozen Mushroom & Onion Pizza, Net Weight: 17 oz. (482g), packaged individually in vacuum-sealed plastic, UPC: 6 66186 27764 5Undeclared soy allergen: soybean oil and soy lecithinClass II · Ongoing
- Wed 14 OctSaint Francis Apizza LLC: Saint Francis Apizza Frozen Supreme Pizza, Net Weight: 17 oz. (482g), packaged individually in vacuum-sealed plastic, UPC: 6 66186 27760 7Undeclared soy allergen: soybean oil and soy lecithinClass II · Ongoing
- Wed 14 OctJ K Patisserie & Bakery LLC: Lemon Blueberry Loaf packaged in a cardboard box; Ingredients: King midas flour, Veribest pastry flour, Granulated Sugar, Blueberries frozen IQF, Milk, Canola Oil, Eggs,…Product contains undeclared soybean oil and soy lecithin in the Ingredient Statement. Soy was not declared in the Contains statement.Class II · Ongoing
- Wed 14 OctJ K Patisserie & Bakery LLC: Chocolate Chip Cookies packaged in a cardboard box; Ingredients: King Midas Special (Wheat flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid, malt…Soy was not declared in the Contains statement.Class II · Ongoing
- Wed 14 OctJ K Patisserie & Bakery LLC: Croissant; packaged in cardboard box; Ingredients: King Midas Special (Wheat flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid, malted barley flou…Egg was not declared in the Contains statement.Class II · Ongoing
- Wed 14 OctSierra Nevada Cheese Company, Inc: SIERRA NEVADA CHEESE GRAZIERS RAW MILK SHARP CHEDDAR NET WT. 40 LBS Item 6516Potential contamination due to E. coli O26:H11.Not Yet Classified · Ongoing
Medicines (US) 100
From the US Food and Drug Administration (openFDA, CC0 1.0). Checked 10 Nov, 06:14 UTC. Dates are the FDA weekly enforcement report the recall appeared in.
- Wed 4 NovThe Ritedose Corporation: Formoterol Fumarate Inhalation Solution, 20mcg/2mL, packaged in cartons of 30 individually wrapped vials (NDC 76204-030-01) and 60 individually wrapped vials (NDC 76204-030-…Failed Impurities/Degradation SpecificationClass II · Ongoing
- Wed 4 NovGlenmark Pharmaceuticals Inc., USA: Abiraterone Acetate Tablets USP 500 mg, 60-count bottles, Rx only, Distributed by: Glenmark Pharmaceuticals USA, Elmwood Park, NJ 07407, NDC 68462-882-60Labeling: Not Elsewhere ClassifiedClass II · Ongoing
- Wed 4 NovSafecor Health, LLC: Metoclopramide Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 51079-886-20.Manufacturer is recalling batches due to co-mingled tablet.Class II · Ongoing
- Wed 4 NovMACLEODS PHARMA USA, INC: Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets 40 mg/10 mg/12.5mg, packaged as a) 30-count bottle, NDC 33342-246-07; b) 90-count bottle, NDC 33342-246-10;…Failed Dissolution Specifications.Class II · Ongoing
- Wed 4 NovHuons Co., Ltd.: Carboxymethylcellulose Sodium, 0.5% Lubricant Eye Drops, Sterile, 30 Single-Use Containers, 0.02 FL OZ (0.5 mL) each, Manufactured by: Huons Co., Ltd, Jecheon-si, Chungcheongbuk-do,…Failed Impurities/Degradation Specification; detection of polyethylene (PE)-related oligomersClass II · Ongoing
- Wed 4 NovProdose, Inc.: ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg, 40-caplets per bottle, Distributed by:Prodose, Inc. Ronkonkoma, NY 11779, Made in India. UPC 8 50026 88900 0Incorrect label placed on product: Outer carton label correctly identifies drug product in bottle as ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg,but inner label on bottle says ValuHealth Extra Strength Pain Relief PMClass III · Ongoing
- Wed 4 NovABC Compounding Co., Inc.: Palm Antiseptic Hand Soap Net Contents: 1 Gallon (3.8 L). Manufactured by: ABC Compounding Co., Inc., 2600 Dogwood Dr., Conyers, GA 30013, UPC 711808196498CGMP DeviationsClass II · Ongoing
- Wed 4 NovABC Compounding Co., Inc.: Aerocare Sani Mango Antiseptic Hand and Body Wash, Net Contents: 1 Gallon (3.8 L), Manufactured By: ABC Compounding Co., Inc., 2600 Dogwood Dr., Conyers, GA 33013, UPC 7118…CGMP DeviationsClass II · Ongoing
- Wed 4 NovABC Compounding Co., Inc.: Aero Foamy Mango Aloe Vera Antiseptic Hand & Body Wash, Net Contents: 1 Gallon (3.8 L), Manufactured by: ABC Compounding Co., Inc., 2600 Dogwood Dr., Conyers, 30013, UPC 71…CGMP DeviationsClass II · Ongoing
- Wed 4 NovABC Compounding Co., Inc.: Certus Medical Satin Foam, 750 ml (25.4 fl. oz.), Manufactured for: Cartus Medical, 2600 Dogwood Dr., Conyers, GA 30013, UPC 711808250930CGMP DeviationsClass II · Ongoing
- Wed 4 NovABC Compounding Co., Inc.: Freshhands Premium Foamy Antibacterial Hand Soap Antiseptic, Net Contents: 18 oz (532 mL), Sold By; Consolidated Chemicals, LLC, 3191 W Tharpe St. Tallahassee, FL 32303 USA…CGMP DeviationsClass II · Ongoing
- Wed 4 NovABC Compounding Co., Inc.: Delta Foremost Sani-Foam Mango, Net Contents: 1000 ML, 33.8 FL OZ, Manufactured Expressly For: Delta Foremost Chemical Corp., 3915 Air Park Street, Memphis, TN 38118,CGMP DeviationsClass II · Ongoing
- Wed 4 NovABC Compounding Co., Inc.: Antiseptic Hand Soap, Net Contents: 1 Gallon (3.8 L) Distributed By: image supply, inc., P.O. Box 1108, 5081 Dawn Drive, Lumberton, NC28359CGMP DeviationsClass II · Ongoing
- Wed 4 NovABC Compounding Co., Inc.: Lynx, LX0864 peachy-foam antiseptic handsoap, 1000 ML (33.8 FL OZ.) Manufactured by: ABC Compounding Co., INC., 2500 Dogwood Dr., Conyers, GA 30013, UPC 711808210804.CGMP DeviationsClass II · Ongoing
- Wed 4 NovABC Compounding Co., Inc.: Lynx, antibacterial hand soap, Net Contents 1 Gallon, (3.8 L), Manufactured by: ABC Compounding Co., INC., 2600 Dogwood Dr., Conyers, GA 30013, UPC 711808199925.CGMP DeviationsClass II · Ongoing
- Wed 4 NovABC Compounding Co., Inc.: Lynx, antibacterial hand soap, Refill, Net Contents 1 Gallon, (3.8 L), Manufactured by: ABC Compounding Co., INC., 2600 Dogwood Dr., Conyers, GA 30013, UPC 711808200027.CGMP DeviationsClass II · Ongoing
- Wed 4 NovABC Compounding Co., Inc.: Handtastic Foamy Mango Antiseptic Foam Soap Hand & Body Wash, Net Contents : 18oz (532ml), Sold by, Momar Incorporated, 1880 Ellsworth Industrial Drive, N.W., Atlanta, Geor…CGMP DeviationsClass II · Ongoing
- Wed 4 NovABC Compounding Co., Inc.: People's FM-24 FOAMING High Foaming Antiseptic Hand and Body Wash, NET CONTENTS: 1000 ML 33.8 FL OZ, Distributed by: People's Janitorial Supply, 955 Main Street, Forest Par…CGMP DeviationsClass II · Ongoing
- Wed 4 NovABC Compounding Co., Inc.: PRO CHEM Fresh Start, Antibacterial Hand Soap, Antiseptic Hand Soap, 800mL bag, Sold by: PRO CHEM, Inc.,1475 Bluegrass Lakes Parkway, Alpharetta, GA 30064.CGMP DeviationsClass II · Ongoing
- Wed 4 NovABC Compounding Co., Inc.: PRO CHEM BAN AID, Antiseptic Hand Soap, Net Contents: 1 GALLON (3.8 L), Sold by: PRO CHEM, Inc.,1475 Bluegrass Lakes Parkway, Alpharetta, GA 30004.CGMP DeviationsClass II · Ongoing
- Wed 4 NovABC Compounding Co., Inc.: Pro Chem Suds Hand Soap, Net Contents: 18 OZ (532 ml), Sold by Pro Chem Inc., 1475 Bluegrass Lakes Parkway, Alpharetta, GA 30004CGMP DeviationsClass II · Ongoing
- Wed 4 NovABC Compounding Co., Inc.: Chemseptic, Net Contents: 1 Gallon (3.8 L), Distributed By: RMC Rochester Midland Corporation, 155 Paragon Drive, Rochester, NY 14624 USA, Made in USACGMP DeviationsClass II · Ongoing
- Wed 4 NovABC Compounding Co., Inc.: Spurrier, Antimicrobial Hand Soap, Net Contents: 1 Gallon (3.8 L), Manufactured by: ABC Compounding Co., Inc., 2600 Dogwood Dr., Conyers, GA, 30013, UPC 726133100508CGMP DeviationsClass II · Ongoing
- Wed 4 NovABC Compounding Co., Inc.: SunCoast Paper Inc. Surgent Antiseptic Hand Soap, Net Contents : 1 Gallon (3.8 L), SunCoast Paper In., 4111 Community Rd., Brunswick, GA 31520, UPC 654441P10219CGMP DeviationsClass II · Ongoing
- Wed 4 NovABC Compounding Co., Inc.: Wechem Hand Guard8/1000mL Bag, Manufactured by: ABC Compounding Co., Inc., 2600 Dogwood Dr., Conyers, GA, 30013CGMP DeviationsClass II · Ongoing
- Wed 4 NovFei Fah Medical Manufacturing Pte. Ltd.: ULTRA STRENTGH, ELECTRIC MIDICATED BALM (menthol 16% and methyl salicylate 32%) packaged in a) Net 2.45 oz (70g) (NDC 63299-001-01) and b) 10g (NDC 63299-001-…CGMP DeviationsClass II · Ongoing
- Wed 4 NovEagle Pharma Outsourcing LLC: PHENYLephrine HCL Infusion, 100 mg per 250 mL in 0.9% Sodium Chloride (0.4 mg/mL), Sterile, Rx Only, Single-Use Container, EAGLE PHARMA OUTSOURCING, 2200 Riverchase Cent…Lack of Assurance of SterilityClass II · Ongoing
- Wed 4 NovEagle Pharma Outsourcing LLC: OXYTOCIN, 30 USP UNITS, Added to 0.9% Sodium Chloride 500 mL - Single-Use Container, Rx Only, EAGLE PHARMA OUTSOURCING, 2200 Riverchase Center, Suite 675, Hoover, AL 352…Lack of Assurance of SterilityClass II · Ongoing
- Wed 4 NovDirect Rx: Lidocaine Ointment USP, 5.0 % 50g JAR, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534, NDC 72189-0211-50Subpotent DrugClass II · Ongoing
- Wed 4 NovMeitheal Pharmaceuticals, Inc: Vecuronium Bromide for Injection, 10mg, 10 Single-Dose Vials per carton, Sterile, Rx Only, Mfd. for Meitheal Pharmaceuticals, Chicago, IL. NDC: 71288-744-11Labeling: Label Lacks Warning or Rx LegendClass III · Ongoing
- Wed 4 NovMeitheal Pharmaceuticals, Inc: Vecuronium Bromide for Injection, 20mg, 10 Single-Dose Vials per carton, Sterile, Rx Only, Mfd. for Meitheal Pharmaceuticals, Chicago, IL. NDC: 71288-745-21Labeling: Label Lacks Warning or Rx LegendClass III · Ongoing
- Wed 4 NovBrandywine Pharmaceuticals, LLC: Theophylline Extended-Release Tablets, 100 mg, Rx Only, 100-count bottle, Distributed by: Brandywine Pharmaceuticals, LLC, West Chester, PA 19382, NDC: 71321-500-10CGMP Deviations: interruption in the ongoing stability testing program conducted at a third-party laboratoryClass II · Ongoing
- Wed 4 NovBrandywine Pharmaceuticals, LLC: Theophylline Extended-Release Tablets, 200 mg, Rx Only, 100-count bottle, Distributed by: Brandywine Pharmaceuticals, LLC, West Chester, PA 19382, NDC: 71321-501-10.CGMP Deviations: interruption in the ongoing stability testing program conducted at a third-party laboratoryClass II · Ongoing
- Wed 4 NovMSN Laboratories Private Limited (Formulations Division, Unit-II): Atorvastatin Calcium Tablets, USP, 40mg, 1000 tablets per bottle, Rx only, Manufactured by: MSL Laboratories Private Limited, Telang…Presence of Foreign Tablets/CapsulesClass II · Ongoing
- Wed 28 OctAscend Laboratories, LLC: Amlodipine and Olmesartan Medoxomil Tablets, 10mg/40mg, 30 Tablets, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsi…Out of specification due to dissolution.Class II · Ongoing
- Wed 28 OctViatris, Inc.: Telmisartan and Amlodipine, Tablets, USP, 40mg/5 mg, 30-count Bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA, Made in India, NDC 0378-1075-93.Superpotent Drug: potential for the Telmisartan content in these lots to exceed specificationsClass III · Ongoing
- Wed 28 OctShenzhen Techdow Pharmaceutical Co., Ltd.: Heparin Sodium Injection, USP, 5,000 USP Units/mL, 1mL Multi dose vial x 25 vials per carton, Distributed by: Hepalink USA Inc., Langhome, PA 19047-1885. Ca…Lack of Assurance of SterilityClass II · Ongoing
- Wed 28 OctPfizer: Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 1000-count bottle, Rx only, Distributed by Pfizer Inc., New York, NY 10017, Made in Austria. NDC 60793-859-10Subpotent Drug: confirmed out-of-specification (OOS) assay during stability testing.Class II · Ongoing
- Wed 28 OctPfizer: Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 100 tablet bottle, Rx only, Distributed by Pfizer Inc., New York, NY 10017, Made in Austria. NDC 60793-859-01.Subpotent Drug: confirmed out-of-specification (OOS) assay during stability testing.Class II · Ongoing
- Wed 28 OctPRITAM INTERNATIONAL PRIVATE LIMITED: Brush Buddies, Barbie, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Bubble Gum Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ont…CGMP DeviationsClass II · Ongoing
- Wed 28 OctPRITAM INTERNATIONAL PRIVATE LIMITED: Brush Buddies, Hot Wheels, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Strawberry Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc.,…CGMP Deviations.Class II · Ongoing
- Wed 28 OctPRITAM INTERNATIONAL PRIVATE LIMITED: Brush Buddies, Crayola, Silly Scents, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Bubble Gum Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel St…CGMP DeviationsClass II · Ongoing
- Wed 28 OctPRITAM INTERNATIONAL PRIVATE LIMITED: Brush Buddies, Crayola, Silly Scents, Anticavity Fluoride Toothpaste, (sodium fluoride0.243%) Watermelon Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Stu…CGMP Deviations.Class II · Ongoing
- Wed 28 OctPRITAM INTERNATIONAL PRIVATE LIMITED: Brush Buddies, Crayola Silly Scents, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Strawberry Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Stu…CGMP Deviations.Class II · Ongoing
- Wed 28 OctPRITAM INTERNATIONAL PRIVATE LIMITED: Brush Buddies, My Little Pony Scents Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Bubble Gum Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Stu…CGMP Deviations.Class II · Ongoing
- Wed 28 OctPRITAM INTERNATIONAL PRIVATE LIMITED: evo, Advanced Whitening, Anticavity Fluoride Toothpaste, (sodium fluoride 0.24%) Peppermint, Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, C…CGMP Deviations.Class II · Ongoing
- Wed 28 OctPRITAM INTERNATIONAL PRIVATE LIMITED: evo, Sensitive, Anticavity Fluoride Toothpaste, (potassium nitrate 5%, sodium fluoride 0.24%) Sweet Mint, Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc…CGMP Deviations.Class II · Ongoing
- Wed 28 OctPRITAM INTERNATIONAL PRIVATE LIMITED: Brush Buddies, Vanilla Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Studio…CGMP DeviationsClass II · Ongoing
- Wed 28 OctPRITAM INTERNATIONAL PRIVATE LIMITED: Brush Buddies, Mint Chocolate Chip Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by A…CGMP Deviations.Class II · Ongoing
- Wed 28 OctPRITAM INTERNATIONAL PRIVATE LIMITED: Brush Buddies, Cookies 'n Cream Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Asht…CGMP Deviations.Class II · Ongoing
- Wed 28 OctPRITAM INTERNATIONAL PRIVATE LIMITED: Brush Buddies, Chocolate Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Stud…CGMP Deviations.Class II · Ongoing
- Wed 28 OctPRITAM INTERNATIONAL PRIVATE LIMITED: Brush Buddies, Whitening Anti-cavity Fluoride Toothpaste, with Baking Soda, (sodium monofluorophosphate 0.76%) Cool Mint, Net Wt. 3.5 oz (99g), Distributed by As…CGMP Deviations.Class II · Ongoing
- Wed 28 OctPRITAM INTERNATIONAL PRIVATE LIMITED: BB (Brush Buddies) Cavity Protection, Anti-Cavity Fluoride Toothpaste, (sodium monofluorophosphate 0.76%) Cool Mint, 2 Value Pack, Two 3.5 oz (99g) tubes, Total…CGMP Deviations.Class II · Ongoing
- Wed 28 OctPRITAM INTERNATIONAL PRIVATE LIMITED: BB (Brush Buddies) Advanced Whitening, Anti-Cavity Fluoride Toothpaste, (sodium fluoride 0,24%) Peppermint, Net Wt 3.5 oz (99g), Distributed by Ashtel Studios In…CGMP Deviations.Class II · Ongoing
- Wed 28 OctPRITAM INTERNATIONAL PRIVATE LIMITED: ARU, Toothpaste, Gum Health, 9 Ingredients, Soothing Mint, (stannous fluoride 0.45%) Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California…CGMP Deviations.Class II · Ongoing
- Wed 28 OctPRITAM INTERNATIONAL PRIVATE LIMITED: ARU, Toothpaste, Cavity Protection, 9 Ingredients, Cool Mint, (sodium fluoride 0.243%) Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, Californ…CGMP Deviations.Class II · Ongoing
- Wed 28 OctRight Value Drug Stores LLC: Testosterone Cypionate, 200 mg/mL, packaged in a) 5 mL vials (NDC 73271-1225-1) and b) 30 m vials ( NDC 73271-1226-2) This Is A Compounded Dug, Intramuscular Use, Office…Lack of sterility assurance.Class II · Ongoing
- Wed 28 OctHikma Pharmaceuticals USA INC.: Abirtega (abiraterone acetate) USP, 250 mg, 120-count bottles, Rx only, Rx only, Mfd for: Hikma Pharmaceuticals USA Inc., Berkley Heights, NJ 07922 USA by: Arab Pharma…Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity.Class II · Ongoing
- Wed 28 OctSTRIDES PHARMA INC: Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, 605 014, India; Distributed by: Strides Pharma Inc. Bridgewater, NJ 0…Failed dissolution specificationsClass II · Ongoing
- Wed 28 OctPar Health USA, LLC: Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA, Malvern,PA 19355/Argatroban Injection, 250 mg/2.5mL (100 mg…Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.Class I · Ongoing
- Wed 28 OctPar Health USA, LLC: Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA, Malvern,PA 19355/ Argatroban Injection, 250 mg/2.5mL (100 m…Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.Class I · Ongoing
- Wed 28 OctGreenwich Rx: Glutathione Injection (Glutathione-L, Ascorbic Acid, Sodium Hydroxide, Bacteriostatic Water), 200 mg/mL, 10 mL multi-dose vial, Rx only, Subcutaneous Only, Greenwich Rx.Microbial Contamination of Sterile ProductsClass I · Ongoing
- Wed 21 OctTeva Pharmaceuticals USA, Inc: Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC 100 Tablets: 0093-2204-01…Presence of Foreign Tablets/CapsulesClass II · Ongoing
- Wed 21 OctZydus Pharmaceuticals (USA) Inc: Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara - 391510 India, Distributed by: Zy…Failed Impurities/Degradation Specifications.Class II · Ongoing
- Wed 21 OctHouston Rx LLC: Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.Lack of assurance of sterility.Class II · Ongoing
- Wed 21 OctHouston Rx LLC: Sermorelin, 1 mg/mL, 10 ml vial, Sterile injectable solution, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.Lack of process controlClass II · Ongoing
- Wed 21 OctAmerican Health Packaging: Metoclopramide Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-620-01; NDC Unit Dose:…Presence of Foreign Tablets/CapsulesClass II · Ongoing
- Wed 14 OctK.C. Pharmaceuticals, Inc.: Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS…Lack of Assurance of SterilityClass II · Ongoing
- Wed 14 OctK.C. Pharmaceuticals, Inc.: Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 251…Lack of Assurance of SterilityClass II · Ongoing
- Wed 14 OctK.C. Pharmaceuticals, Inc.: Sterile EYE DROPS Advanced Relief, (dextran 70, 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles, Sterile; a) LEADER, DISTRIBUTE…Lack of Assurance of SterilityClass II · Ongoing
- Wed 14 OctK.C. Pharmaceuticals, Inc.: Eye Drops MAXIMUM, REDNESS RELIEF, Sterile, 1/2 FL OZ (0.5 ML); a) exchange select, Manufactured for your Military Exchange By: K.C Pharmaceuticals, Inc., Pomona, CA 9176,…Lack of Assurance of SterilityClass II · Ongoing
- Wed 14 OctK.C. Pharmaceuticals, Inc.: Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0502-1; b) Crocod…Lack of Assurance of SterilityClass II · Ongoing
- Wed 14 OctK.C. Pharmaceuticals, Inc.: Sterile Eye Drops, ORIGINAL, Tetrahydrozoline HCl 0.05% Redness Reliever ¿ Fast Acting Formula) Product size: 0.5 fl oz (15 mL); a) Best Choice, PROUDLY DISTRIBUTED BY: VA…Lack of Assurance of SterilityClass II · Ongoing
- Wed 14 OctK.C. Pharmaceuticals, Inc.: Sterile Eye Drops Redness Relief (Glycerin 0.25%, Naphazoline HCl 0.02% Lubricant | Redness Reliever) (Relieves Dryness, Burning and Irritations), 0.5 fl oz (15 mL); a) LE…Lack of Assurance of SterilityClass II · Ongoing
- Wed 14 OctK.C. Pharmaceuticals, Inc.: Sterile High Performance Ultra Lubricating Eye Drops (Polyethylene Glycol 400, 0.4% Relieves Dry and Irritated Eyes) Product size: 0.5 fl oz (15 mL); a) LEADER, DISTRIBUTE…Lack of Assurance of SterilityClass II · Ongoing
- Wed 14 OctBioSpectra, Inc.: Biospectra Tris/Tromethamine, USP, GMP, API Grade, Manufactured at 100 Majestic Way, Bangor, PA 18013, NDC 64173-101-25Failed stability specificationsClass II · Ongoing
- Wed 14 OctPreferred Pharmaceuticals, Inc.: Lidocaine Ointment USP, 5% (Generic for Xylocaine), packaged in a 50 g jar, Rx only, Mfg: Taro Pharmaceuticals U.S.A., Inc., Prod# (NDC): 68788-7865-05Failed Content Uniformity SpecificationsClass II · Ongoing
- Wed 14 OctCipla USA, Inc.: Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by: Cipla Ltd., Kurkumbh-413802, Maharashtra, I…Failed Impurities/Degradation SpecificationsClass II · Ongoing
- Wed 14 OctJ&J INNOVATIVE MEDICINE: IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only, Manufactured by: Janssen Biotech, Inc…Presence of particulate matter.Class II · Ongoing
- Wed 14 OctCarolina Infusion, LLC: TIRZEPATIDE 26 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees C…Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.Class II · Ongoing
- Wed 14 OctCarolina Infusion, LLC: SEMAGLUTIDE 3 MG/ML INJECTABLE, 8 x 0.1 mL syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.Class II · Ongoing
- Wed 14 OctCarolina Infusion, LLC: SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusio…Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.Class II · Ongoing
- Wed 14 OctCarolina Infusion, LLC: SERMORELIN ACETATE 1 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95…Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.Class II · Ongoing
- Wed 14 OctCarolina Infusion, LLC: QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion…Lack of Assurance of Sterility: Related to processing equipment used in compounded product.Class II · Ongoing
- Wed 14 OctCarolina Infusion, LLC: Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infus…Lack of Assurance of Sterility: Related to processing equipment used in compounded product.Class II · Ongoing
- Wed 14 OctCarolina Infusion, LLC: Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infus…Lack of Assurance of Sterility: Related to processing equipment used in compounded product.Class II · Ongoing
- Wed 14 OctCarolina Infusion, LLC: Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infu…Lack of Assurance of Sterility: Related to processing equipment used in compounded product.Class II · Ongoing
- Wed 14 OctCarolina Infusion, LLC: Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infus…Lack of Assurance of Sterility: Related to processing equipment used in compounded product.Class II · Ongoing
- Wed 14 OctCarolina Infusion, LLC: SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusio…Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.Class II · Ongoing
- Wed 14 OctCarolina Infusion, LLC: TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusi…Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.Class II · Ongoing
- Wed 14 OctCarolina Infusion, LLC: TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusi…Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.Class II · Ongoing
- Wed 14 OctCarolina Infusion, LLC: TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusi…Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.Class II · Ongoing
- Wed 14 OctCarolina Infusion, LLC: TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusi…Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.Class II · Ongoing
- Wed 14 OctCarolina Infusion, LLC: Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infus…Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.Class II · Ongoing
- Wed 14 OctCarolina Infusion, LLC: Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95…Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.Class II · Ongoing
- Wed 14 OctSUN PHARMACEUTICAL INDUSTRIES INC: Tretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawtho…Failed Impurities/Degradation SpecificationsClass III · Ongoing
- Wed 14 OctSUN PHARMACEUTICAL INDUSTRIES INC: Tretinoin Cream USP, 0.05%, 45 g tube, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada…Failed Impurities/Degradation SpecificationsClass III · Ongoing
- Wed 14 OctSUN PHARMACEUTICAL INDUSTRIES INC: Tretinoin Cream UPS, 0.05%, 20g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne,…Failed Impurities/Degradation SpecificationsClass III · Ongoing
- Wed 14 OctApothecary Pharma LLC: Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC 27513, NDC 85091-001-18.Lack of Assurance of SterilityClass II · Ongoing
- Wed 14 OctApothecary Pharma LLC: Apothecary NAD+ Injection 200 mg/mL, 6 mL Sterile Multi-Dose Vial, Rx Only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC, 27513, NDC 85091-011-06.Lack of Assurance of SterilityClass II · Ongoing
All medicines recalls on the Food and Drug Administration site
Medical devices (US) 232
From the US Food and Drug Administration (openFDA, CC0 1.0). Checked 10 Nov, 06:14 UTC. Dates are the FDA weekly enforcement report the recall appeared in.
- Wed 4 NovAbiomed, Inc.: Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump.Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that may result in failure of the AIC to recognize the purge cassette during case setup or cassette change. This issue may result in delay in procedure or therapy. 2. Potential for the rotary push button (RPB) sticking and unreliable actuation impa…Class I · Ongoing
- Wed 4 NovAbiomed, Inc.: Impella Optical Controller, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump.Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that may result in failure of the AIC to recognize the purge cassette during case setup or cassette change. This issue may result in delay in procedure or therapy. 2. Potential for the rotary push button (RPB) sticking and unreliable actuation impa…Class I · Ongoing
- Wed 4 NovAbiomed, Inc.: Impella Connect Optical AIC, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump.Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that may result in failure of the AIC to recognize the purge cassette during case setup or cassette change. This issue may result in delay in procedure or therapy. 2. Potential for the rotary push button (RPB) sticking and unreliable actuation impa…Class I · Ongoing
- Wed 4 NovEthicon, LLC: ETHILON Nylon Suture, Product Code 697GNylon suture indicated for use in general soft tissue approximation and/or ligation may have needles with distorted curvature, that may break during use, or could cause additional soft tissue or vessel injury, including tearing or bleeding intraoperatively.Class II · Ongoing
- Wed 4 NovMedtronic, Inc.: OmniaSecure Model 3930M, LEAD 3930M74 74 CM DF4 MR 3930M74 LEAD 3930M79 79 CM DF4 MR 3930M79 The Medtronic OmniaSecure" Model 3930M lead is a steroid eluting, integrated bipolar, non…Affected leads require additional engineering evaluation due to complaints regarding difficulty in achieving fixation during implantation. Potential harm of tissue trauma due to implant difficulty.Class II · Ongoing
- Wed 4 NovZIEHM-ORTHOSCAN INC: Orthoscan VERSA Accessory Cart, REF: 1000-0021 and Versa Mini C-Arm System, REF: 1000-0020The accessory cart weldment does not conform to weld dimensional specifications which may result in separation of the monitor arm mounting structure from the cart.Class II · Ongoing
- Wed 4 NovPhilips North America: Model Number: 712010.Potential for the device to fail immediately after an exposure, causing the system to remain stationary.Class II · Ongoing
- Wed 4 NovCanon Medical System, USA, INC.: ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000CDue to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis function is use.Class II · Ongoing
- Wed 4 NovCanon Medical System, USA, INC.: ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000FDue to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis function is use.Class II · Ongoing
- Wed 4 NovCanon Medical System, USA, INC.: ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000VDue to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis function is use.Class II · Ongoing
- Wed 4 NovPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion 3 M12. Model Numbers: 722063, 722221.Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.Class II · Ongoing
- Wed 4 NovPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion 3 M15. Model Number: 722064, 722222, 722280.Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.Class II · Ongoing
- Wed 4 NovPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion 5 M12. Model Number: 722227.Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.Class II · Ongoing
- Wed 4 NovPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion 5 M20. Model Numbers: 722228, 722281.Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.Class II · Ongoing
- Wed 4 NovPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion 7 B12. Model Numbers: 722067, 722225.Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.Class II · Ongoing
- Wed 4 NovPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion 7 B20. Model Numbers: 722068, 722226.Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.Class II · Ongoing
- Wed 4 NovPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion 7 M12. Model Numbers: 722078, 722223.Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.Class II · Ongoing
- Wed 4 NovPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion 7 M20. Model Numbers: 722079, 722224, 722282.Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.Class II · Ongoing
- Wed 4 NovPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion S. Model Number: 722285.Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.Class II · Ongoing
- Wed 4 NovBioMerieux SA: EMAG system Model/Catalog Number: 418591/418591U Product Description: Nucleic acid sample preparation instrument IVD, automatedDelayed or no result when analyzing clinical samples with EMAG system (ref: 418591/418591U) due to a randomly occurring software error, Error 10003 Heater timeout after updating to recent firmware SP4 Patch 2Class II · Ongoing
- Wed 4 NovMedtronic, Inc.: CareLink SmartSync Programmer, Model 24970A, Pulse generator, permanent, implantableSoftware problem has the potential for an inaccurate displayed longevity estimate.Class II · Ongoing
- Wed 4 NovMedtronic, Inc.: CareLink SmartSync, RF Head Patient Connector, Model 24967, Pulse generator, permanent, implantableSoftware problem has the potential for an inaccurate displayed longevity estimate.Class II · Ongoing
- Wed 4 NovMedtronic, Inc.: CareLink SmartSync Device Manager App, Model M01A02, Pulse generator, permanent, implantableSoftware problem has the potential for an inaccurate displayed longevity estimate.Class II · Ongoing
- Wed 4 NovPentax of America Inc: PENTAX Medical Ultrasound Endoscope. Model Number. EG36-J10UR.Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure.Class II · Ongoing
- Wed 4 NovPentax of America Inc: PENTAX Medical Ultrasound Endoscope. Model Numbers. EG38-J10UT, EG34-J10U.Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure.Class II · Ongoing
- Wed 4 NovPentax of America Inc: PENTAX Medical Ultrasound Endoscope. Model Numbers. EG-3870UTK, EG-3670URK.Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure.Class II · Ongoing
- Wed 4 NovPentax of America Inc: PENTAX Medical Ultrasound Endoscope. Model Number. EG-3270UK.Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure.Class II · Ongoing
- Wed 4 NovPentax of America Inc: PENTAX Medical Water bottle assembly. Model Number. OS-H5.Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure.Class II · Ongoing
- Wed 4 NovBoston Scientific Neuromodulation Corporation: Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu Neurostimulation SystemTherapy Disc (TD) that powers and sends stimulation signals to an Implantable Pulse Generator (IPG), part of a neurostimulation system, has a firmware issue that causes the TD to attempt to restart, then fail, leading it to become non-functional, and if a secondary TD is unavailable, this may lead IPG to become non-functional, thus unable to inhibit transmission of pain signals.Class II · Ongoing
- Wed 4 NovStryker Leibinger GmbH & Co. KG: Precision Pointer Electromagnetic (8000-050-001)Device may fracture during use at the laser welded joint on the pointer tube. If this happens, loose parts may fall out of the product while the device is inside the patient.Class II · Ongoing
- Wed 4 NovARJOHUNTLEIGH POLSKA Sp. z.o.o.: Carevo, Height-adjustable shower trolley, Model Number BAC1111-01The side support of the shower trolley may open unintentionally when the handles are not fully locked and additional force is applied during patient handling. If the side support is not fully locked and an additional force is applied by the caregiver on the handle (e.g., during turning or repositioning), the panel may open unintentionally, which can lead to a resident/patient fall and serious inj…Class II · Ongoing
- Wed 28 OctVentec Life Systems, Inc.: VOCSN+Pro, Model Number:PRT-00490-001, Package PN:PRT-00853-000. used for ventilatory support.Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.Class I · Ongoing
- Wed 28 OctVentec Life Systems, Inc.: VOCSN+Pro (Japan), Model Number: PRT-00490-100, Package PN:PRT-00853-100. used for ventilatory support.Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.Class I · Ongoing
- Wed 28 OctVentec Life Systems, Inc.: VC+Pro Model Number: PRT-00900-001, Package PN:PRT-00973-000. used for ventilatory support.Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.Class I · Ongoing
- Wed 28 OctVentec Life Systems, Inc.: VC+Pro (Japan) Model Number: PRT-00900-100, Package PN:PRT-00973-100. used for ventilatory support.Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.Class I · Ongoing
- Wed 28 OctVentec Life Systems, Inc.: VOCSN Model Number: PRT-01100-000, Package PN:PRT-01126-000. used for ventilatory support.Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.Class I · Ongoing
- Wed 28 OctVentec Life Systems, Inc.: VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support.Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.Class I · Ongoing
- Wed 28 OctVentec Life Systems, Inc.: VCSN+Pro Model Number: PRT-01184-000, Package PN:PRT-01172-000. used for ventilatory support.Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.Class I · Ongoing
- Wed 28 OctVentec Life Systems, Inc.: V+Pro Model Number: PRT-01185-000, Package PN:PRT-01198-000; Model Number: PRT-01185-001, Package PN: N/A; Model Number: PRT-01185-002, Package PN:N/A. used for ventilatory…Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.Class I · Ongoing
- Wed 28 OctVentec Life Systems, Inc.: VC Model Number: PRT-01098-000, Package PN:PRT-01125-000. used for ventilatory support.Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.Class I · Ongoing
- Wed 28 OctVentec Life Systems, Inc.: VC(Japan) Model Number: PRT-01098-100, Package PN:PRT-01125-100. used for ventilatory support.Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.Class I · Ongoing
- Wed 28 OctVentec Life Systems, Inc.: V+ Pro Emergency, Model Number: PRT-01201-000, Package PN:PRT-01173-000,PRT-01222-000. used for ventilatory support.Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.Class I · Ongoing
- Wed 28 OctVentec Life Systems, Inc.: V*Home, Model Number: PRT-01444-000, Package PN:PRT-01445-000. used for ventilatory support.Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.Class I · Ongoing
- Wed 28 OctPhilips Ultrasound, LLC: Philips Lumify Diagnostic Ultrasound SystemUltrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular access, which may be unavailable outside of the hospital (ambulances/aircraft/field); 2) At connection between transducer USB cable to tablet/phone, there may be an unstable connection/may disconnect disrupting function. May cause diagnosis/treatment delay.Class I · Ongoing
- Wed 28 OctAbbott: Amplatzer Amulet Left Atrial Appendage Occluder Model Numbers 1. 9-ACP2-007-016 2. 9-ACP2-007-018 3. 9-ACP2-007-020 4. 9-ACP2-007-022 5. 9-ACP2-010-025 6. 9-ACP2-010-028 7. 9-ACP2-010-031 8.…Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI).Class II · Ongoing
- Wed 28 OctThink Surgical, Inc.: Think Surgical Square Driver REF: 109126Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during drilling.Class II · Ongoing
- Wed 28 OctB Braun Medical Inc: B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068.Potential for leakage and backflow at the Safsite valve.Class II · Ongoing
- Wed 28 OctMedtronic Navigation, Inc.: Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/Tray 12 pk., RxonlySterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.Class II · Ongoing
- Wed 28 OctMedtronic Navigation, Inc.: Medtronic NDI Passive Spheres REF: 8801074, Sterile EO, 4/Tray 12 Pk., RxonlySterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.Class II · Ongoing
- Wed 28 OctMedtronic Navigation, Inc.: Medtronic NDI Passive Spheres REF: 8801075, Sterile EO, 5/Tray 12 Pk., RxonlySterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.Class II · Ongoing
- Wed 28 OctMedtronic Navigation, Inc.: Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, RxonlySterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.Class II · Ongoing
- Wed 28 OctAxonics, Inc.: PNE Lead Implant Kit REF: 1701Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users.Class II · Ongoing
- Wed 28 OctPhilips North America: Philips Smart-hopping 2.0 AP 1.4 GHz; Product/Model Number: 867216;Unreliable wireless roaming behavior of Smart-hopping 1.0 wireless clients during transport when connecting to Smart-hopping 2.0 infrastructure, resulting in loss of connectivity to the central monitoring system (PIC iX).Class II · Ongoing
- Wed 28 OctGreiner Bio-One North America, Inc.: Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog Number: 454008P Product Description: Greiner VACUETTE Blood Collection Tube with Lit…Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely elevated potassium (K+) and falsely decreased calcium (Ca++) results which have the potential to cause hyperkalemia.Class II · Ongoing
- Wed 28 OctBeckman Coulter, Inc.: ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846 and A94469), Optima XPN-90 (Model Num…Optima XE XPN ultracentrifuge rotors may contain a microstructure defect that can cause rotors to break into two or more pieces (bifurcate) during a centrifugation run, resulting in destruction of samples being processed. When used for in vitro diagnostic (IVD) sample preparation, rotor breakage may delay patient test results. Additionally, sample destruction may expose laboratory personnel to bi…Class II · Ongoing
- Wed 28 OctBeckman Coulter, Inc.: ROTOR ASSY-SW41, Reference Number 331362, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846 and A94469), Optima XPN-90 (Model Num…Rotors have been found with a non-conforming microstructure, which may result in some rotors breaking into two or more pieces during use. Rotors that break into multiple pieces during use may result in significant damage to materials (i.e., samples) being processed in the centrifuge and to the centrifuge instrument.Class II · Ongoing
- Wed 28 OctMedtronic MiniMed, Inc.: CareLink Clinic, REF: MMT-7350CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calculation logic fails to use custom values entered by healthcare professionals (HCPs) for Total Daily Dose (TDD) or Long-acting insulin when calculating the Carb Ratio, Insulin Sensitivity Factor (ISF), and Max Recommended value for Rapid-acting insulin. Instead, the calculator conti…Class II · Ongoing
- Wed 28 OctCooperVision, Inc.: Generic Name: Softmed Breathables Advanced Toric (fanfilcon A) Soft (Hydrophilic) Contact Lens; Model/Catalog Number: Softmed Breathables Advanced Toric Product Description: 55% w…The affected products bear an incorrect statement on the carton packaging indicating that the product is "Indicated for Extended Wear". However, this product is intended for daily wear, and the extended-wear statement should not have appeared on the affected carton labeling. This product is not approved by the U.S. Food and Drug Administration (FDA) for extended wear use.Class II · Ongoing
- Wed 28 OctTECHNO-PATH MANUFACTURING LTD.: Techno-Path Multichem AE Unassayed Level 1 REF:AE621XA routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing confirmed that the labelled shelf-life performance claim for the Ammonia analyte can no longer be supported for the affected lots. This issue is limited to the Ammonia analyte only. The impacted device may cause delay of i…Class II · Ongoing
- Wed 28 OctTECHNO-PATH MANUFACTURING LTD.: Techno-Path Multichem AE Unassayed Level 2 REF: AE622XA routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing confirmed that the labelled shelf-life performance claim for the Ammonia analyte can no longer be supported for the affected lots. This issue is limited to the Ammonia analyte only. The impacted device may cause delay of i…Class II · Ongoing
- Wed 28 OctTECHNO-PATH MANUFACTURING LTD.: Techno-Path Multichem AE Unassayed Level 3, REF:AE623XA routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing confirmed that the labelled shelf-life performance claim for the Ammonia analyte can no longer be supported for the affected lots. This issue is limited to the Ammonia analyte only. The impacted device may cause delay of i…Class II · Ongoing
- Wed 28 OctLife Technologies Holdings Pte Ltd: Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated SequencerDNA or RNA sequencing system software has vulnerabilities.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/105; Material Number: M001195200The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/130; Material Number: M001195210The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/155; Material Number: M001195220The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/105; Material Number: M001195230The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/130; Material Number: M001195240The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/155; Material Number: M001195250The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/105; Material Number: M001195260The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/130; Material Number: M001195270The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/155; Material Number: M001195280The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Number: M001195290The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/130; Material Number: M001195300The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/155; Material Number: M001195310The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/130; Material Number: M001195320The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/155; Material Number: M001195330The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/130; Material Number: M001195340The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/155; Material Number: M001195350The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/105; Material Number: M001195400The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/130; Material Number: M001195410The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/155; Material Number: M001195420The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/105; Material Number: M001195430The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/130; Material Number: M001195440The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/155; Material Number: M001195450The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/130; Material Number: M001195470The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/155; Material Number: M001195480The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/130; Material Number: M001195500The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/155; Material Number: M001195510The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/130; Material Number: M001195610The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/155; Material Number: M001195620The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/130; Material Number: M001195640The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/155; Material Number: M001195650The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/2RO/130; Material Number: M001195660The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/2RO/130; Material Number: M001195670The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/130; Material Number: M001195710The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/155; Material Number: M001195720The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/130; Material Number: M001195740The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155; Material Number: M001195750The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/STRAIGHT/1RO/130; Material Number: M001195810The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/130; Material Number: M001195840The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/155; Material Number: M001195850The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/STRAIGHT/1RO/130; Material Number: M001195910The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 OctBoston Scientific Cork, Ltd.: Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/BERN/1RO/130; Material Number: M001195940The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.Class II · Ongoing
- Wed 28 Octrestor3d Inc.: Generic Name: restor3d MTP Implant Generic Name: MTP Implant Model/Catalog Number: 1103-161620 Software Version: None Product Description: The restor3d Metatarsophalangeal (MTP) Implan…Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization.Class II · Ongoing
- Wed 28 OctMedtronic MiniMed, Inc.: Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600 (iOS), MMT-8601 (Android) Software Version: Software version 1.2.1 Product Descriptio…A software defect in which existing users who had previously configured and enabled the long-acting dose reminder feature in version 1.2.0 or earlier experienced failure of the long-acting dose reminder after updating their app to version 1.2.1. The long-acting dose reminder is an optional feature that, when enabled, triggers a notification at the scheduled time to remind users to take their long…Class II · Ongoing
- Wed 28 OctMedtronic Neuromodulation: InterStim SureScan MRI Leads 978A1 & 978B1: LEAD 978A128 ISTM MICRO 28CM SSMRI TINED 978A128 LEAD 978A133 ISTM MICRO 33CM SSMRI TINED 978A133 LEAD 978A141 ISTM MICRO 41CM S…Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may result in delay of surgery or need for surgical replacement of the product.Class II · Ongoing
- Wed 28 OctMedtronic Neuromodulation: InterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030 ISTM MICRO PERC 3560030Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may result in delay of surgery or need for surgical replacement of the product.Class II · Ongoing
- Wed 28 OctSolstice Corporation: Xact mole marker for mammography Model/Catalog Number: M15RMThe radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material.Class II · Ongoing
- Wed 28 OctMedline Industries, LP: MEDLINE DRAPE C-SECTION W/POUCH ST 7/CS, Medline Product Number/SKU DYNJP6101Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.Class II · Ongoing
- Wed 28 OctMedline Industries, LP: MEDLINE DRAPE C-SEC FEN CLEAR SCRN WIRE, Medline Product Number/SKU DYNJP6106Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.Class II · Ongoing
- Wed 28 OctMedline Industries, LP: MEDLINE DRAPE C-SECTION FEN CLR SCREEN W, Medline Product Number/SKU DYNJP6108Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.Class II · Ongoing
- Wed 28 OctMedline Industries, LP: MEDLINE medical convenience kits labeled as: FETOSCOPY CDS-LF, Medline Product Number/SKU CDS840215PReports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.Class II · Ongoing
- Wed 28 OctMedline Industries, LP: MEDLINE medical convenience kits labeled as: C-SECTION PACK, Medline Product Number/SKU DYNJ48455AReports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.Class II · Ongoing
- Wed 28 OctMedline Industries, LP: MEDLINE medical convenience kits labeled as: 1) FETAL SURGERY CDS-LF, Medline Kit Number/SKUCDS840214R; 2) MAJOR, Medline Kit Number/SKUDYNJ904851I; 3) ABDOMINAL TRANSPLANT, M…Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.Class II · Ongoing
- Wed 28 OctMedline Industries, LP: MEDLINE medical convenience kits labeled as (list truncated)Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.Class II · Ongoing
- Wed 28 OctMedline Industries, LP: MEDLINE medical convenience kits labeled as: 1) BIRTHDAY KIT-DOUBLE BASIN-LF, Medline Kit Number/SKU DYNJ16127N; 2) NYGH-DELIVERY PACK-LF, Medline Kit Number/SKU DYNJ27206D; 3…Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.Class II · Ongoing
- Wed 28 OctMedline Industries, LP: MEDLINE medical convenience kits labeled as: 1) LAPAROTOMY GYN CDS, Medline Kit Number/SKU CDS983529O; 2) GYN ROBOTIC PK-LF, Medline Kit Number/SKU DYNJ52432M; 3) TAH PACK, Me…Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.Class II · Ongoing
- Wed 28 OctMedline Industries, LP: MEDLINE medical convenience kits labeled as: (list truncated)Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.Class II · Ongoing
- Wed 28 OctMedline Industries, LP: MEDLINE medical convenience kits labeled as: TUBAL LIGATION RFD, Medline Product Number/SKU DYNJ906291GReports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.Class II · Ongoing
- Wed 28 OctMedline Industries, LP: MEDLINE medical convenience kits labeled as: C-SECTION TRAY-LF, Medline Kit Number/SKU OBN471KReports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.Class II · Ongoing
- Wed 28 OctMedline Industries, LP: MEDLINE medical convenience kits labeled as: 1) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64103C; 2) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64155B.Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.Class II · Ongoing
- Wed 28 OctAVID Medical, Inc.: Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH31.A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.Class II · Ongoing
- Wed 28 OctAVID Medical, Inc.: Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH30.A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.Class II · Ongoing
- Wed 21 OctInstrumentation Laboratory: HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnosticPotential for invalid calibration curve or negative mean bias of up to 47% with patient samples.Class I · Ongoing
- Wed 21 OctInstrumentation Laboratory: HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.Class I · Ongoing
- Wed 21 OctJenavalve Technology Inc.: JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-SDelivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.Class II · Ongoing
- Wed 21 OctJenavalve Technology Inc.: JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-MDelivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.Class II · Ongoing
- Wed 21 OctJenavalve Technology Inc.: JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-LDelivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.Class II · Ongoing
- Wed 21 OctMedtronic Sofamor Danek USA Inc: Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft produc…Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed finished product sterility testing Medtronic is retrieving any unused product manufactured from the donor tissue. Donor bone tissue tested positive for Clostridium butyricum and w…Class II · Ongoing
- Wed 21 OctMedtronic Sofamor Danek USA Inc: Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft produc…Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed finished product sterility testing Medtronic is retrieving any unused product manufactured from the donor tissue. Donor bone tissue tested positive for Clostridium butyricum and w…Class II · Ongoing
- Wed 21 OctBecton Dickinson & Co.: BD Phoenix Panel NMIC-312. Catalog Number: 449082.Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.Class II · Ongoing
- Wed 21 OctBecton Dickinson & Co.: BD Phoenix Panel NMIC-306. Catalog Number: 449292.Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.Class II · Ongoing
- Wed 21 OctCadwell Industries Inc: Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653 Product Description: The IOMAX Cortical Module contains a 16…Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrical stimulation to the patient, or allow an unintended electrical current to reach the patient.Class II · Ongoing
- Wed 21 OctNeuronetics, Inc.: NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below NeuroStar Advanced Therapy Systems: 1. NeuroStar 2.0 US; Part…Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.Class II · Ongoing
- Wed 21 OctBoston Scientific Corporation: NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device configuration.Class II · Ongoing
- Wed 21 OctSarnova HC, Llc: Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack (10 pk), Item Number 670272-KITAffected kits were assembled with pediatric nasal cannula instead of the intended adult nasal cannula.Class II · Ongoing
- Wed 21 OctFerno-Washington Inc: Power F2 Powered Fastening System, Power F2, Item No. 0567093 used with Power X2 Stretchers, Power X2, Item No. 0015816 and PowerX2 Premium, Item No. 0015821Firmware issue may result in intermittent loss or degradation of powered functionality when paired with compatible stretcher. The issue may lead to the system not operating in powered mode, or exhibiting reduced powered performance. Issue may result in interruption or delay in patient transport.Class II · Ongoing
- Wed 21 OctSI-BONE, Inc.: iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.Class II · Ongoing
- Wed 21 OctINTEGRATED MEDCRAFT LLC: FORWARD Gunshot Wound Kit; Model: AFT-GSW;Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad, potentially causing the sterile pad to degrade over time. The degradation may cause remnants of the nonwoven pad material to dislodge on the wound or in close proximity to the wound.Class II · Ongoing
- Wed 21 OctBioFire Diagnostics, LLC: Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Panel Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verif…Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive resultsClass II · Ongoing
- Wed 21 OctBioFire Diagnostics, LLC: Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel plus Model/Catalog Number: RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit) Software Vers…Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive resultsClass II · Ongoing
- Wed 21 OctBioFire Diagnostics, LLC: Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection (JI) Panel Model/Catalog Number: RFIT-ASY-0138 (30 Kit), RFIT-ASY-0135 (6 Kit) Softw…Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive resultsClass II · Ongoing
- Wed 21 OctBaxter Healthcare Corporation: Likorall Overhead Lifts Product Code: 3121001 Product Description: LIKORALL 200 Product Code: 3122005 Product Description: LIKORALL 242 ES, NATURAL Product Code: 312200…Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instances where the lift strap lowers more quickly than expected during use. Patients are at some risk for injury if a significant fall/drop were to occur due to this issue.Class II · Ongoing
- Wed 21 OctEthicon, LLC: PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271HSilk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surgical delay. If used, fluid could cause reduced suture tensile strength or knot security, tissue irritation/inflammatory tissue response, and treatment failure, including wound dehiscence/bleeding.Class II · Ongoing
- Wed 21 OctSteris Corporation: RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in clo…Class II · Ongoing
- Wed 21 OctSteris Corporation: RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in clo…Class II · Ongoing
- Wed 21 OctSteris Corporation: RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in clo…Class II · Ongoing
- Wed 21 OctIn2bones USA, LLC: REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mmDue to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.Class II · Ongoing
- Wed 21 OctW L Gore & Associates, Inc.: Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: The GORE VIABIL Short Wire Biliary Endopro…The potential for the devices to be mislabeled with the incorrect length.Class II · Ongoing
- Wed 21 OctMicrogenics Corporation: MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF: OPRO-101; MAS Omni IMMUNETM PRO Liquid Assayed Integrated Immunoassay Control, Sample Pack, R…Vial-to-vial variability in MAS¿ Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, Lot OPRO29061A results in low Parathyroid Hormone (PTH) recovery, which may lead to a delay in reporting patient PTH results.Class II · Ongoing
- Wed 21 OctBeckman Coulter, Inc.: DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual preventive maintenance (PM) requirements without adequate reliability evaluation. When the check valve is not replaced annually, it may allow lamina fluid to migrate internally and leak…Class II · Ongoing
- Wed 21 OctBeckman Coulter, Inc.: IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997; IQ200 SELECT, REF: 700-3340, 700-3345, 700-3347, B48998, C10684; IQ200 ELITE, REF: 700-3370, 700-3375, 700-…The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual preventive maintenance (PM) requirements without adequate reliability evaluation. When the check valve is not replaced annually, it may allow lamina fluid to migrate internally and leak…Class II · Ongoing
- Wed 21 OctMagellan Diagnostics, Inc.: LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2026. If used the system will display an error message and prevent the operator from running the test. Resulting in delayed results.Class III · Ongoing
- Wed 21 OctCook Incorporated: Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part Number 090001-S26, Order Number (GPN) G16112The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing. Potential events that may occur as a result of this issue include increased procedural time and inadequate treatment.Class II · Ongoing
- Wed 21 OctHowmedica Osteonics Corp.: TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.Class II · Ongoing
- Wed 21 OctHowmedica Osteonics Corp.: TS Femoral Prep Tray, Triathlon. Catalog Number: 6543-6-507.Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.Class II · Ongoing
- Wed 21 OctHowmedica Osteonics Corp.: Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.Class II · Ongoing
- Wed 21 OctHowmedica Osteonics Corp.: TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519.Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.Class II · Ongoing
- Wed 21 OctMedline Industries, LP: Medline surgical convenience kits labeled as: CABG AUXILIARY PACK, Medline Product Number/SKU DYNJ44925DMedical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.Class II · Ongoing
- Wed 21 OctMedline Industries, LP: 1) Product Name AUD OPEN HEART PACK, Medline Kit Number/SKU DYNJ22052I; 2) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528N; 3) Product Name AV SHUNT PAC…Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.Class II · Ongoing
- Wed 21 OctMedline Industries, LP: Medline surgical convenience kits labeled as: 1) OPEN HEART CDS, Medline product number/SKU CDS840094R; 2) OPEN HEART CDS, Medline product number/SKU CDS840171AG; 3) MHC AV FI…Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.Class II · Ongoing
- Wed 21 OctMedline Industries, LP: Medline surgical convenience kits labeled as: 1) VEIN HARVESTING PACK-LF, Medline product number/SKU DYNJ0826732J; 2) NBMC VASCULAR PACK-LF, Medline product number/SKU DYNJ066…Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.Class II · Ongoing
- Wed 21 OctMedline Industries, LP: Medline surgical convenience kits labeled as: VEIN HARVESTING PACK, Medline product number/SKU DYNJ51845DMedical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.Class II · Ongoing
- Wed 21 OctMedline Industries, LP: Medline surgical convenience kits labeled as: 1) EAR, Medline product number/SKU DYNJ909020B; 2) EAR, Medline product number/SKU DYNJ909020A; 3) CAROTID PACK, Medline product…Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.Class II · Ongoing
- Wed 21 OctMedline Industries, LP: Medline surgical convenience kits labeled as: 1) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AC; 2) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product n…Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.Class II · Ongoing
- Wed 21 OctMedline Industries, LP: Medline surgical convenience kits labeled as: 1) CV BASIN PACK-LF, Medline Product number/SKU DYNJ0538615K; 2) CV BASIN PACK-LF, Medline product number/SKU DYNJ0538615J; 3) CV…Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.Class II · Ongoing
- Wed 21 OctMedline Industries, LP: Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & B, Medline Product number/SKU DYNJ04584L; 2) OPEN HEART ACCESSORY PACK, Medline Product number/SKU DYN…Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.Class II · Ongoing
- Wed 21 OctMedline Industries, LP: Medline surgical convenience kits labeled as: 1) NEURO-SPINE BASIN PACK, Medline Product Number/SKU DYNJ80055A; 2) AV SHUNT PACK-LF, Medline Product Number/SKU DYNJ24528M.Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.Class II · Ongoing
- Wed 21 OctMedline Industries, LP: Medline surgical convenience kits labeled as: OPEN HEART, Medline Product Number/SKU DYNJ902898DMedical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.Class II · Ongoing
- Wed 21 OctMedline Industries, LP: Medline surgical convenience kits labeled as: 1) SPINAL CDS, Medline Product Number/SKU CDS940087AM; 2) CUSTOM CRANI, Medline Product Number/SKU DYNJ907697C; 3) FEM POP PACK-L…Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.Class II · Ongoing
- Wed 21 OctMedline Industries, LP: Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135 LAP CHOLE DYNJ911660 LAP NISSEN DYNJ911560 UROLOGY LAPAROSCOPIC - 51638 DYNJ908720AKits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.Class II · Ongoing
- Wed 21 OctMedline Industries, LP: Convenience Kits containing CONMED AirSeal Access Ports HERNANDEZ DAVINCI ACC BUNDLE M DYNJ911258 KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I ROBOTIC CHEST DYNJ910997 DYNJ91099…Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.Class II · Ongoing
- Wed 21 OctMedline Industries, LP: Convenience Kits containing CONMED AirSeal Access Ports GENERAL DAVINCI DYNJG901004C LAP CHOLE DYNJ88071 ROBOTIC PACK DYNJ50474FKits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.Class II · Ongoing
- Wed 21 OctMedline Industries, LP: Convenience Kits containing CONMED AirSeal Access Ports CHN GYN ONCOLOGY DYNJ906731K DYNJ906731L DYNJ906731N DAVINCI PROSTATECTOMY DYNJG901002A DYNJG901002B DYNJG901002C DYNJG…Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.Class II · Ongoing
- Wed 21 OctMedline Industries, LP: Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135A CHN GYN ONCOLOGY DYNJ906731MKits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.Class II · Ongoing
- Wed 21 OctMedline Industries, LP: Convenience Kits containing CONMED AirSeal Access Ports KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116GKits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.Class II · Ongoing
- Wed 21 OctINTELERAD MEDICAL SYSTEMS INCORPORATED: IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5-2-1-R93, PACS-5-3-1-R83 through R128, PACS-5-4-1-R66 through R101, PACS-5-5-1-R50…Following a Chromium-based web-browser, report and displayed images may not match.Class II · Ongoing
- Wed 21 OctMerit Medical Systems, Inc.: Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance System, Rx Only, Sterile-EOThe implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.Class II · Ongoing
- Wed 21 OctHealthmark Industries Co., Inc.: Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H - WHITE, Model Number 09-1-011; 2) WHITE VENTED INSTRUMENT GUARD 1/16 X 3/4, Model Number…Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated.Class II · Ongoing
- Wed 21 OctMedline Industries, LP: Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395ADiscrepancy in the shelf-life of a componentClass II · Ongoing
- Wed 21 OctRadiometer Medical ApS: The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environme…In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood samples no longer suitable for testing FHbF and ctBil, 2) Reportable ranges for some parameters, 3) Analyzer configuration, and 4) limitations and warnings.Class II · Ongoing
- Wed 14 OctMedical Action Industries, Inc. 306: Generic Name: Kit, Urine, Clean Catch Trade Name: Kit: Urinary Clean Catch 20/cs Model/Catalog Number: 76769 Lot Number: 333606 UDI-DI: 20809160118228 Software Ve…An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027.Class III · Ongoing
- Wed 14 OctSteris Corporation: VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reductionClass II · Ongoing
- Wed 14 OctSteris Corporation: VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reductionClass II · Ongoing
- Wed 14 OctSteris Corporation: VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3060Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reductionClass II · Ongoing
- Wed 14 OctSteris Corporation: VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reductionClass II · Ongoing
- Wed 14 OctSteris Corporation: VERIFY Biological Steam Test Pack Model/Catalog Number: S3065Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reductionClass II · Ongoing
- Wed 14 OctSteris Corporation: VERIFY Biological Steam Test Pack Model/Catalog Number: S3069Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reductionClass II · Ongoing
- Wed 14 OctQUANTUM OPS Inc: Brand Name: ADAPTABLE Beach Chair Product Name: Beach Chair surgical patient positioner Model/Catalog Number: 804-33-300 (Enovis); 3105-400-030 (Stryker); internal BC-0001 / BC-0220…Due to a manufacturing issue (inadequate weld) for patient head positioning system.Class II · Ongoing
- Wed 14 OctGRI Medical & Electronic Technology Co., Ltd.: HALYARD Laparoscopy Comprehensive Pack II REF: 49332Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheterClass II · Ongoing
- Wed 14 OctPHILIPS MEDICAL SYSTEMS: Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.); Model Numbers: 1. 728333 (U.S. and Outside U.S.), 2. 728340 (…Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion.Class II · Ongoing
- Wed 14 OctCardinal Health 200, LLC: Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366085 AN2336608H AN2336608J Intubating Bag Kit Catalog Number OMS…Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in disconnecting the adapter from the patient's endotracheal tube to perform a procedure. The issue can result in a delay to treatment and unintended extubation. The potential exists for respiratory failure, hypoxia, aspiration, or low oxygen saturation.Class II · Ongoing
- Wed 14 OctLimitless Cryo Spa LLC: Glypto Device, Glypto Cryo Machine;Lack of 510(k) clearance.Class II · Ongoing
- Wed 14 OctSafeguard US Operating LLC: Battle Bandage, REF: 32-700; Patrol IFAK Bag, Black - Advanced, REF: 81-125-BL; Patrol IFAK Bag, Multicam - Advanced, REF: 81-125-MC; Patrol IFAK II, Olive Drab, Stocked (…Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration and irrigation, formation of scar tissue, and infection.Class II · Ongoing
- Wed 14 OctDRG International, Inc.: Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);Potential for false negative patient results.Class II · Ongoing
- Wed 14 OctBeckman Coulter Inc.: DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3. Access 2 Module, DxC 500i, Part No.…Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the draft configuration in the System Configuration page may cause the analyzer to revert the test units to the system default…Class II · Ongoing
- Wed 14 OctBeckman Coulter Inc.: DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the draft configuration in the System Configuration page may cause the analyzer to revert the test units to the system defau…Class II · Ongoing
- Wed 14 OctStryker Sustainability Solutions: BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma formation from particulate matter.Class II · Ongoing
- Wed 14 OctMedline Industries, LP: Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support while walking,…The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the front wheels may become loose or detach from the rollator. If the front wheels become loose or detach during use, there is risk of severe adverse events. The immediate consequences could include falls resulting in head tr…Class II · Ongoing
- Wed 14 OctMedline Industries, LP: Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support while walking, Prod…The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the front wheels may become loose or detach from the rollator. If the front wheels become loose or detach during use, there is risk of severe adverse events. The immediate consequences could include falls resulting in head tr…Class II · Ongoing
- Wed 14 OctMedtronic MiniMed, Inc.: Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Description: The MiniMed Flex pump is an alternate controll…Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results in one or more of 9 functional tests. The unverified/failed pumps released to users potentially have one or more of the following issues: inoperable pump at setup, lack of protection for moisture exposure, slow battery char…Class II · Ongoing
- Wed 14 OctNihon Kohden America LLC: Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software Version: software versions: 01-03, 01-04, 01-05, 01-06, 02-10, 02-11…Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds and the visualization of alarms.Class II · Ongoing
- Wed 14 OctOnkos Surgical, Inc.: Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04MPersonalized pelvic implants inadvertently mixed up and distributed to incorrect customers.Class II · Ongoing
- Wed 14 OctOnkos Surgical, Inc.: Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04MPersonalized pelvic implants inadvertently mixed up and distributed to incorrect customers.Class II · Ongoing
- Wed 14 OctAVID Medical, Inc.: DAVINCI TRUCUSTOM BUNDLE; Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064-28;Product may be potentially contaminated with a lubricant used during the manufacturing process.Class II · Ongoing
- Wed 14 OctAVID Medical, Inc.: GYN LAPAROSCOPY/LAPAROTOMY; Model/Item Number (Kit): 1. WRNM002-15, 2. FBCH108-03;Product may be potentially contaminated with a lubricant used during the manufacturing process.Class II · Ongoing
- Wed 14 OctAVID Medical, Inc.: ADULT HEART TRAY SHANDS JACKS; Model/Item Number (Kit): SHND419-08;Product may be potentially contaminated with a lubricant used during the manufacturing process.Class II · Ongoing
- Wed 14 OctAVID Medical, Inc.: ENDOVASCULAR PACK; Model/Item Number (Kit): VAPX014-04;Product may be potentially contaminated with a lubricant used during the manufacturing process.Class II · Ongoing
- Wed 14 OctAVID Medical, Inc.: CRANIOTOMY PACK; Model/Item Number (Kit): WRNM035-20;Product may be potentially contaminated with a lubricant used during the manufacturing process.Class II · Ongoing
- Wed 14 OctAVID Medical, Inc.: PACK OPEN HEART CFH; Model/Item Number (Kit): 1. UFCF004-06, 2. UFCF004-07;Product may be potentially contaminated with a lubricant used during the manufacturing process.Class II · Ongoing
- Wed 14 OctAVID Medical, Inc.: ROBOTIC PROSTATECTOMY PACK; Model/Item Number (Kit): NAMC423-11;Product may be potentially contaminated with a lubricant used during the manufacturing process.Class II · Ongoing
- Wed 14 OctAVID Medical, Inc.: LAPAROSCOPIC PROSTATECTOMY; Model/Item Number (Kit): NIHB0036-07;Product may be potentially contaminated with a lubricant used during the manufacturing process.Class II · Ongoing
- Wed 14 OctAVID Medical, Inc.: PLASTICS TRAY; Model/Item Number (Kit): EURO053;Product may be potentially contaminated with a lubricant used during the manufacturing process.Class II · Ongoing
- Wed 14 OctAVID Medical, Inc.: DAVINCI LAP/GYN; Model/Item Number (Kit): WRNM037-16;Product may be potentially contaminated with a lubricant used during the manufacturing process.Class II · Ongoing
- Wed 14 OctAVID Medical, Inc.: HEART PREP TRAY; Model/Item Number (Kit): MECV97W;Product may be potentially contaminated with a lubricant used during the manufacturing process.Class II · Ongoing
- Wed 14 OctAVID Medical, Inc.: UROLOGY MAJOR; Model/Item Number (Kit): WRNM058-10;Product may be potentially contaminated with a lubricant used during the manufacturing process.Class II · Ongoing
- Wed 14 OctAVID Medical, Inc.: MAJOR PACK; Model/Item Number (Kit): NIHB0018-11;Product may be potentially contaminated with a lubricant used during the manufacturing process.Class II · Ongoing
- Wed 14 OctAVID Medical, Inc.: GYN LAPAROSCOPY PACK; Model/Item Number (Kit): NAMC436-12;Product may be potentially contaminated with a lubricant used during the manufacturing process.Class II · Ongoing
- Wed 14 OctAVID Medical, Inc.: ABD HYSTERECTOMY; Model/Item Number (Kit): NAMC438-07;Product may be potentially contaminated with a lubricant used during the manufacturing process.Class II · Ongoing
- Wed 14 OctPOLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC: SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to detach or be forcibly ejected, potentially resulting in the release of blood and exposure of the operator or surrounding work area to a biological hazard (blood).Class II · Ongoing
- Wed 14 OctCanon Medical System, USA, INC.: Alphenix INFX-8000C/B5Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion errorClass II · Ongoing
- Wed 14 OctMindray DS USA, Inc.: ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10ACertain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functionsClass III · Ongoing
- Wed 14 OctMindray DS USA, Inc.: BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functionsClass III · Ongoing
- Wed 14 OctMindray DS USA, Inc.: BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functionsClass III · Ongoing
- Wed 14 OctMindray DS USA, Inc.: Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functionsClass III · Ongoing
- Wed 14 OctMindray DS USA, Inc.: BeneView Series. Operator's Manuals: T5 / T8Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functionsClass III · Ongoing
- Wed 14 OctMindray DS USA, Inc.: Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / VCertain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functionsClass III · Ongoing
- Wed 14 OctMindray DS USA, Inc.: cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functionsClass III · Ongoing
- Wed 14 OctMindray DS USA, Inc.: T1 Patient Monitor. Operator's Manual: T1 Patient MonitorCertain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functionsClass III · Ongoing
- Wed 14 OctLeMaitre Vascular, Inc.: TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.Class II · Ongoing
- Wed 14 OctSteris Corporation: HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and environmental control, Software Version: 2…A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a documentation discrepancy or incorrect association of clinical images with a patient record.Class II · Ongoing
- Wed 14 OctIntellijoint Surgical, Inc.: Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint HIP, Portable System, REF: 000-0249A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery, subject to an Apple battery recall, that may overheat and pose a fire safety risk.Class II · Ongoing
All medical devices recalls on the Food and Drug Administration site
Product safety (UK) 58
From the UK Office for Product Safety and Standards (Open Government Licence v3.0). Checked 10 Nov, 06:14 UTC.
- Fri 6 NovProduct Recall: 1000W Bagless Cylinder Vacuum Cleaner sold via eBay (2610-0246)Product Recall for 1000W Bagless Cylinder Vacuum Cleaner presenting a risk of fire.
- Fri 6 NovProduct Recall: Petite Amélie Wooden Mobile Holder (2611-0018)Product Recall for Petite Amélie Wooden Mobile Holder presenting a high risk of injuries.
- Fri 6 NovProduct Safety Report: Cube Squeeze Ball sold via Amazon (2609-0078)Product Safety Report for Cube Squeeze Ball presenting a chemical risk.
- Fri 6 NovProduct Safety Report: Urban Arrow Cargo Bikes fitted with Satori Trident Seat Post (2610-0216)Product Safety Report for Urban Arrow Cargo Bikes fitted with Satori Trident Seat Post presenting a risk of injuries.
- Fri 6 NovProduct Safety Report: VTEK Cordless Reciprocating Saw sold via Amazon (2610-0149)Product Safety Report for VTEK Cordless Reciprocating Saw presenting a high risk of fire and electric shock.
- Fri 6 NovProduct Safety Report: Yongkang Yongchang Electric Tools Co Ltd Cordless Drill sold via Amazon (2610-0235)Product Safety Report for Yongkang Yongchang Electric Tools Co Ltd Cordless Drill presenting a serious risk of electric shock and fire.
- Thu 5 NovProduct Recall: Wednesday Addams Costume sold via eBay (2609-0105)Product Recall for Wednesday Addams Costume sold via eBay presenting a serious risk of burns.
- Wed 4 NovProduct Safety Report: 2200W Vertical Steam Iron sold via eBay (2610-0199)Product Safety Report for 2200W Vertical Steam Iron presenting a high risk of fire.
- Wed 4 NovProduct Safety Report: GEARLASSO Vehicle Battery Charger sold via Amazon (2610-0131)Product Safety Report for GEARLASSO Vehicle Battery Charger presenting a serious risk of fire.
- Wed 4 NovProduct Safety Report: LEDSone UK Ltd AC-DC Power Supply Adapter (2610-0165)Product Safety Report for LEDSone UK Ltd AC-DC Power Supply Adapter presenting a serious risk of fire.
- Wed 4 NovProduct Safety Report: Moon-shaped Baby Sleep Pillow (2610-0055)Product Safety Report for Moon-shaped Baby Sleep Pillow presenting a serious risk of suffocation.
- Wed 4 NovProduct Safety Report: Omani Brothers Umm Khammas Henna Paste (2610-0033)Product Safety Report for Omani Brothers Umm Khammas Henna Paste presenting a serious chemical risk
- Mon 2 NovProduct Recall: Ancient Wisdom Bath Donut (2610-0144)Product Recall for Ancient Wisdom Bath Donut presenting a serious risk of choking.
- Mon 2 NovProduct Recall: ASDA Ladies’ Handbags (2609-0009)Product Recall for ASDA Ladies’ Handbags presenting a serious chemical risk.
- Mon 2 NovProduct Recall: Decathlon Electric Assistance for Stand-Up Paddleboard (SUP) and Battery (2610-0191)Product Recall for Decathlon Electric Assistance for Stand-Up Paddleboard (SUP) and Battery presenting a serious risk of fire and burns.
- Mon 2 NovProduct Recall: Piper K Bag Charms – Seal Lifeguard and Duck in Dungarees sold by TK Maxx (2607-0266)Product Recall for Piper K Bag Charms – Seal Lifeguard and Duck in Dungarees presenting a serious risk of choking.
- Mon 2 NovProduct Safety Report: Move2Play Baby Gym Basic sold via Amazon (2610-0234)Product Safety Report for Move2Play Baby Gym Basic presenting a risk of choking and asphyxiation.
- Mon 2 NovProduct Safety Report: Move2Play Baby Gym Deluxe sold via Amazon (2610-0190)Product Safety Report for Move2Play Baby Gym Deluxe presenting a risk of choking.
- Mon 26 OctProduct Recall: HAMAX Buddy Baby Seat (2610-0181)Product Recall for HAMAX Buddy Baby Seat presenting a risk of choking.
- Mon 26 OctProduct Safety Report: 20,000pcs Runfeng Water Beads (2607-0041)Product Safety Report for 20,000pcs Runfeng Water Beads presenting a serious risk of asphyxiation.
- Mon 26 OctProduct Safety Report: Baby Sleeping Bags sold via AliExpress (2610-0182)Product Safety Report for Baby Sleeping Bags sold via AliExpress presenting a risk of asphyxiation.
- Mon 26 OctProduct Safety Report: Baby Sleeping Bags sold via Amazon (2610-0176)Product Safety Report for Baby Sleeping Bags sold via Amazon presenting a risk of asphyxiation.
- Mon 26 OctProduct Safety Report: Baby Sleeping Bags sold via Etsy (2610-0180)Product Safety Report for Baby Sleeping Bags sold via Etsy presenting a risk of asphyxiation.
- Mon 26 OctProduct Safety Report: Baby Sleeping Bags sold via OnBuy (2610-0183)Product Safety Report for Baby Sleeping Bags sold via OnBuy presenting a risk of asphyxiation.
- Mon 26 OctProduct Safety Report: Baby Sleeping Bags sold via Wish (2610-0185)Product Safety Report for Baby Sleeping Bags sold via Wish presenting a risk of asphyxiation.
- Mon 26 OctProduct Safety Report: Blue Starfish Shaped Baby Sleeping Bag sold via Joom (2610-0186)Product Safety Report for Blue Starfish Shaped Baby Sleeping Bag sold via Joom presenting a risk of asphyxiation.
- Mon 26 OctProduct Safety Report: Crochet Baby Sleeping Bag sold via Vinted (2610-0184)Product Safety Report for Crochet Baby Sleeping Bag sold via Vinted presenting a risk of asphyxiation.
- Fri 23 OctProduct Safety Report: Babymore Space Saver Cot (Grey) (2610-0027)Product Safety Report for Babymore Space Saver Cot presenting a risk of injuries.
- Fri 23 OctProduct Safety Report: Goose Patting Baby Sleep Pillow sold via Wish (2610-0177)Product Safety Report for Goose Patting Baby Sleep Pillow presenting a serious risk of suffocation.
- Fri 23 OctProduct Safety Report: Rully Children's Bike sold via Amazon (2610-0175)Product Safety Report for Rully Children's Bike presenting a high risk of injuries.
- Thu 22 OctProduct Recall: Axkid MiniKid Core Car Seats (2609-0213)Product Recall for Axkid MiniKid Core Car Seats.
- Thu 22 OctProduct Safety Report: Candle Warmer Lamp, TL-167 (2610-0093)Product Safety Report for Candle Warmer Lamp, TL-167 presenting a serious risk of electric shock.
- Thu 22 OctProduct Safety Report: Xin Yue AC PC Power Cable (2610-0158)Product Safety Report for Xin Yue AC PC Power Cable presenting a high risk of fire.
- Thu 22 OctProduct Safety Report: Kovar Windproof Camping Stove (2610-0157)Product Safety Report for Kovar Windproof Camping Stove presenting a risk of burns.
- Thu 22 OctProduct Safety Report: Leafless Hair Dryer (2610-0107)Product Safety Report for Leafless Hair Dryer presenting a serious risk of fire.
- Thu 22 OctProduct Safety Report: Shark Tail Baby Sleeping Bag sold via Wish (2610-0064)Product Safety Report for Shark Tail Baby Sleeping Bag sold via Wish presenting a serious risk of asphyxiation.
- Wed 21 OctProduct Recall: Horace Vetiver Primavera Beard Oil sold via Amazon (2609-0073)Product Recall for Horace Vetiver Primavera Beard Oil presenting a health risk.
- Wed 21 OctProduct Safety Report: 2.6M Telescopic Ladder (2610-0102)Product Safety Report for 2.6M Telescopic Ladder presenting a serious risk of injuries.
- Wed 21 OctProduct Safety Report: Animal-Shaped Baby Sleep Pillow sold via Wish (2610-0087)Product Safety Report for Animal-Shaped Baby Sleep Pillow presenting a serious risk of suffocation.
- Wed 21 OctProduct Safety Report: LED Ceiling Light, JM6001 (2610-0098)Product Safety Report for LED Ceiling Light, JM6001 presenting a serious risk of fire.
- Wed 21 OctProduct Safety Report: SOKANY 4-in-1 Corded Bagless Vacuum Cleaner (2610-0069)Product Safety Report for SOKANY 4-in-1 Corded Bagless Vacuum Cleaner presenting a risk of fire.
- Tue 20 OctProduct Safety Report: Todimart T1 and T3 Electric Children’s Scooter sold via Amazon (2610-0119)Product Safety Report for Todimart T1 and T3 Electric Children’s Scooter presenting a risk of fire.
- Mon 19 OctProduct Recall: Ambiano Ionic Hairdryers sold by Aldi (2610-0111)Product Recall for Ambiano Ionic Hairdryers sold by Aldi presenting a high risk of electric shock.
- Mon 19 OctProduct Safety Report: Soft Plastic Alien Mask sold via Amazon (2610-0040)Product Safety Report for Soft Plastic Alien Mask presenting a serious risk of asphyxiation.
- Mon 19 OctProduct Safety Report: Xuanhua 25m Caravan Extension Lead sold via Amazon (2610-0097)Product Safety Report for Xuanhua 25m Caravan Extension Lead presenting a serious risk of fire.
- Fri 16 OctProduct Recall: Pimple Popping Squishes containing needles sold via AliExpress (2610-0049)Product Recall for Pimple Popping Squishes containing needles sold via AliExpress presenting a risk of injuries.
- Tue 13 OctProduct Recall: Aginode LANmark-OF Micro-Bundle Universal 12x Multimode Cable (2507-0172)Product Recall for Aginode LANmark-OF Micro-Bundle Universal 12x Multimode Cable presenting a risk of fire.
- Tue 13 OctProduct Recall: Mattressman Comforcel Elite and Supreme Mattresses (2609-0226)Product Recall for Mattressman Comforcel Elite and Supreme Mattresses presenting a risk of fire.
- Tue 13 OctProduct Recall: Mint Velvet Raya Espadrille Wedge Sandals sold by Next (2610-0072 and 2610-0192)Product Recall for Mint Velvet Raya Espadrille Wedge Sandals presenting a risk of injuries.
- Tue 13 OctProduct Recall: Oren Kablo CAT7 S/FTP 300m Ethernet Cable (2510-0089)Product Recall for Oren Kablo CAT7 S/FTP 300m Ethernet Cable presenting a risk of fire.
- Tue 13 OctProduct Safety Report: AutoJare Multi-Function Cordless Drill (2609-0230)Product Safety Report for AutoJare Multi-Function Cordless Drill presenting a high risk of fire.
- Tue 13 OctProduct Safety Report: Baby Electric Soothing Palm Sleep Pillow sold via AliExpress (2610-0015)Product Safety Report for Baby Electric Soothing Palm Sleep Pillow presenting a serious risk of asphyxiation.
- Tue 13 OctProduct Safety Report: Eskute C100 Plus Electric Bicycle (2610-0010)Product Safety Report for Eskute C100 Plus Electric Bicycle presenting a risk of injuries.
- Tue 13 OctProduct Safety Report: Frideko Home LED Floor Lamp sold via Amazon (2610-0006)Product Safety Report for Frideko Home LED Floor Lamp sold via Amazon presenting a high risk of electric shock.
- Tue 13 OctProduct Safety Report: InteDesign Plush Caterpillar Toys sold via Amazon (2609-0224)Product Safety Report for InteDesign Plush Caterpillar Toys presenting a high risk of asphyxiation, choking and strangulation.
- Tue 13 OctProduct Safety Report: Mini Chainsaw, 4L (2609-0234)Product Safety Report for Mini Chainsaw, 4L presenting a serious risk of electric shock.
- Tue 13 OctProduct Safety Report: OOWOLF LED Light sold via Amazon (2609-0221)Product Safety Report for OOWOLF LED Light presenting a high risk of electric shock.
- Tue 13 OctProduct Safety Report: Toddler Ghost Costume sold via Amazon (2609-0106)Product Safety Report for Toddler Ghost Costume presenting a serious risk of strangulation and asphyxiation.
All consumer products recalls on the Office for Product Safety and Standards site
Weekly Recalls lists notices exactly as the agencies publish them and adds no advice. If you own an affected product, follow the instructions in the agency's notice. Australia, Canada and the EU aren't included yet.