Weekly RecallsRecalls this week
101 notices from official recall feeds in the 7 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) 12
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…
All consumer products recalls on the Consumer Product Safety Commission site
Food (US) 12
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
Medicines (US) 34
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
All medicines recalls on the Food and Drug Administration site
Medical devices (US) 31
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
All medical devices recalls on the Food and Drug Administration site
Product safety (UK) 12
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
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.