Archive
771 recalls were announced in June 2021.
Of the 771 recalls this month scored against our rubric, 1% are Critical, 15% are Severe.
Which agencies issued them
Medtronic is recalling HY10L28R3 perfusion system tubing packs (lot 221679870) manufactured with insufficient or incomplete welds. The recall affects units distributed in nine U.S. states.
WorkMate Claris v.1.2 Upgrade Kits may lose functionality or display a black screen during operation due to a software error.
Medtronic is recalling Custom Pack HY10D90R2 sterile perfusion system tubing packs manufactured with insufficient or incomplete welds, which could compromise device integrity during use.
Ossur Americas is recalling the MIAMI J SELECT COLLAR cervical spine device due to deforming racks that may reduce immobilization. About 10,469 units were distributed nationwide.
Corin Ltd is recalling TriIFit TS size 2 hip prosthesis stems that were labeled incorrectly as TriFit CF size 7 stems, and vice versa. Patients receiving mismatched implants face risk of poor fit and potential complications.
Medtronic is recalling specific lots of BB9G78R8 ECC perfusion system tubing packs due to insufficient or incomplete welds that may compromise device integrity.
Medtronic is recalling 18 tubing packs used in perfusion systems due to potentially incomplete or insufficient welds that may compromise device integrity. No injuries have been reported.
Radiometer Medical ApS recalls E3800 PC Units spare parts due to an internal clock defect affecting analyzers. Approximately 965 units have been distributed worldwide, with 35 in the United States.
Medtronic is recalling specific lots of HY10Z48R2 Adult ECC Custom Perfusion System tubing packs due to potential weld defects. Affected units may have insufficient or incomplete welds that could compromise device function.
The FS32 monitor mounting brackets may loosen and detach from their base, potentially injuring patients or staff. FDA recalls affected units.
R.C. Willett is recalling NorthStar 8.5 Arrow U truck campers with specific Dometic stoves because an over-tightened bolt may damage the seal, causing a gas leak and fire risk.
Medtronic is recalling specific lots of CB10Y89R10 custom perfusion system tubing packs due to insufficient or incomplete welds. The affected lots were distributed in nine U.S. states.
Medtronic is recalling specific lots of CB1H18R20 Custom Perfusion System tubing packs because they may have been manufactured with insufficient or incomplete welds. No injuries have been reported.
Porsche is recalling 2021 911 models because an incorrect passenger seat may cause the Occupant Classification System to malfunction, potentially affecting the front passenger air bag.
Radiometer is recalling ABL90 FLEX PLUS Analyzers with E3800 PC units due to an internal clock issue. Approximately 4,135 units are affected worldwide, including 1,277 in the United States.
Lamborghini is recalling 2018-2021 Huracan vehicles because the rearview camera may fail to display in cold temperatures, increasing crash risk.
Medtronic has recalled 16 tubing packs from its CB10R79R6 Custom Perfusion System due to insufficient or incomplete welds in specific lots. The defect may compromise device integrity during use.
Corin TriFit hip prosthesis components from lot 467881 were mislabeled, with size 2 stems labeled as size 7 and vice versa. Surgeons could implant incorrect components during hip replacement surgery.
Medtronic is recalling 7 neonatal perfusion system tubing sets manufactured under lot 221387901 with insufficient or incomplete welds. The affected sets were distributed nationwide across nine states.
Medtronic recalls custom perfusion system tubing packs due to potential manufacturing defects in welds. Specific lots may have insufficient or incomplete welds that could affect system integrity.
Medtronic recalls Custom Perfusion System tubing packs due to incomplete welds in the manufacturing process that may affect device integrity.
Medtronic Perfusion System tubing packs are recalled due to manufacturing defects involving insufficient or incomplete welds in the CB10W63R1 lot. Affected devices may malfunction during use.
Medtronic is recalling specific lots of CB7J98R7 Custom Pack perfusion system tubing because some units may have insufficient or incomplete welds. The defect could affect device performance during cardiac surgery.
Medtronic is recalling specific lots of CB4W67R20 Custom Perfusion System tubing packs due to incomplete welds that could affect system performance. The recall affects 61 packs distributed across nine states.
Medtronic is recalling perfusion system tubing packs due to manufacturing defects involving incomplete or insufficient welds. No injuries have been reported, but the defect may affect product performance and safety.
Natural Foods Inc is recalling BulkFoods.com brand Vegetable Mixture in multiple sizes due to potential Salmonella contamination in the celery component. The recall affects products distributed across 22 states.
Specific lots of Medtronic's CB10W65R1 perfusion system tubing packs may have incomplete or insufficient welds that could compromise system integrity during cardiac surgery.
World Source LLC is recalling QiYu Hand Sanitizer Gel (500 mL bottles) distributed to two hospitals in New York because the product is subpotent—meaning it contains less active ingredient than specified.
Dr. Reddy's Laboratories is recalling Atorvastatin Calcium Tablets USP 10 mg nationwide because certain lots contain impurities that exceeded acceptable specifications.
Prisma Health Outsourcing Facility is recalling Ketamine HCl Injection Solution (10 mg / 2 mL) distributed in South Carolina due to incorrect expiration dates and incorrect Beyond Use Dates (BUD) on the labeling.
AVKARE Inc. is recalling Phytonadione Tablets 5 mg because the impurity degradant D level failed to meet specification. The affected lot was distributed in Los Angeles, California.
Johnson & Johnson Vision Care is recalling certain ACUVUE VITA soft contact lenses due to potential incomplete packaging seals. Only a limited number of packages from LOT # BOOWWWL are affected.
Lopez Gonzalez Santana Corporation is recalling BTREX PLUS Dietary Supplement (100 caplets, UPC 05380930801, Lot #30636, Exp. 01/2022) due to the presence of damaged tablets resulting from manufacturing deviations.
Lopez Gonzalez Santana Corporation is recalling BTREX PLUS dietary supplement 2-caplet bottles (Lot #30637, expiration 01.2022) due to the presence of damaged tablets resulting from Current Good Manufacturing Practice (CGMP) deviations.
Cummins is recalling certain ISL remanufactured diesel engines because a sealing washer may not seat correctly, allowing the high-pressure fuel rail to leak and increasing fire risk.
LeMans Corporation is recalling specific Drag Specialties replacement laced motorcycle rear wheels because misaligned spoke holes could cause broken spokes and wheel failure.
Altec is recalling 2020-2021 AT200A, AT235, and AT235P aerial devices because insufficient strength bolts may fail, causing the pedestal to separate and increasing the risk of injury or death.
KZRV is recalling 2021 Connect travel trailers because low tongue weight may cause instability at highway speeds, increasing crash risk.
Trailstar is recalling 2017-2019 Dump Trailers because the steering arm may detach, potentially causing loss of steering control or road hazards.
Nissan is recalling 2020-2021 Sentra vehicles because the left or right tie rod may be bent. A bent tie rod can break, causing loss of steering control and increasing crash risk.
Daimler Trucks North America is recalling 2018-2022 Thomas Built Saf-T-Liner HDX school buses because incorrect seat configurations may fail to provide proper crash protection.
Sealight is recalling S1H11 LED headlight bulbs that create excessive glare, failing federal safety standards and increasing crash risk.
Certain 2020-2021 Land Rover Discovery vehicles have a loose battery ground contact causing electrical failure and potential vehicle shutdown while driving. Dealers will replace the ground stud at no cost.
General Motors recalls certain 2021 Chevrolet Tahoe and related vehicles due to a power steering software issue that may cause loss of steering assist, increasing crash risk.
Spartan Fire is recalling 2019-2021 S-180 Pumper emergency vehicles because a pump shift harness defect may prevent the vehicle from shifting into pump mode.
Temsa is recalling 2014-2020 TS45 buses because a rusted wire on the roof emergency exit handle may break, delaying evacuation.
Marion Body Works is recalling 2019-2021 Spartan Fire Metrostar and Gladiator vehicles because the power steering pump shaft seal may break, causing loss of assist.
Heartland Recreational Vehicles is recalling certain 2021 Mallard and other trailers because LP gas lines on outside cooktops may not have been tightened properly, creating a risk of gas leaks and fire.
Terex Advance is recalling 188 units of 2021 Front Discharge Mixers because a shaft key was not installed properly, which could cause unintentional chute movement and increase the risk of injury.
Avid Medical is recalling 160 fistula care kits due to potential contamination from Aspergillus penicillioides fungal growth in a component applicator. The contamination could breach the kit's package integrity and affect other sterile components.
BCFoods, Inc. is recalling certain BC Foods AD Celery Stalk products because an ingredient tested positive for Salmonella. The affected products are sold in bulk fiber cartons to food service and manufacturing customers.
Frito-Lay is recalling Ruffles All Dressed Potato Chips due to the potential presence of undeclared milk. Consumers with milk allergies who purchased the affected product should not consume it.
DeRoyal Angio Cath Removal Tray contains mislabeled anesthetic; the label indicates 1% Lidocaine but the tray actually contains 0.5% Bupivacaine. This FDA Class I recall affects 60 trays distributed in MS, VA, LA, and NY.
365 Everyday Value Whey Protein Powder was mistakenly packaged with Soy Protein Powder. The affected canisters were distributed nationwide and may pose a risk to consumers with soy allergies.
Smiths Medical recalls 1,432,200 Jelco insulin syringes with skewed graduation markings that could lead to incorrect dosing. Specific lot numbers are affected.
INNOVA Medical Group is recalling SARS-CoV-2 antigen rapid test kits distributed to customers not enrolled in an authorized clinical investigation.
Sun Hong Foods is recalling Seafood Mushroom (5.3 oz packages) distributed to California, Texas, Washington, Illinois, Florida, and New York due to potential Listeria monocytogenes contamination identified in product testing by the California Department of Public Health.
DeRoyal Industries is recalling 66 heart catheterization procedure packs due to mislabeling of anesthetic contents. The packs contain 0.5% Bupivacaine but are labeled as containing 1% Lidocaine, creating a medication error risk during surgery.
Hy-Vee is recalling Chicken Street Taco kits because the chipotle crema component contains undeclared egg, a major food allergen. The product was distributed to Hy-Vee stores across multiple states.
Gilster-Mary Lee Corp. is recalling Organic Microwave Butter Popcorn because butter microwave popcorn bags were packaged in organic salted popcorn consumer boxes, resulting in undeclared milk in the product. The recall affects 413 cases distributed to multiple states.
BC Foods is recalling Celery Stalk and Leaf Dice due to an ingredient testing positive for Salmonella. The product was distributed to food manufacturers and distributors across eight states.
Avid Medical is recalling 720 Fistula On-Off Kits due to potential fungal contamination that may compromise package integrity. The BD ChloraPrep applicator component may develop Aspergillus penicillioides, which could contaminate other kit components.
Avid Medical is recalling medical dialysis access kits due to potential fungal growth in an applicator component that may compromise the package seal and contaminate other components. Approximately 560 kits distributed nationwide are affected.
Innova Medical Group recalled COVID-19 self-test kits distributed to customers outside of clinical investigation requirements. About 1,206 tests in 402 boxes were distributed across the U.S., Canada, India, and the United Kingdom.
DeRoyal is recalling surgical procedure packs due to mislabeling. The product contains 0.5% Bupivacaine but is labeled as 1% Lidocaine, creating a medication identification error.
Innova Medical Group is recalling COVID-19 self-test kits distributed to customers outside an authorized clinical investigation. The recall affects 370 boxes of tests distributed nationwide and internationally.
Rainfield Marketing Group is recalling 150g packages of Enoki Mushroom (UPC 085412004020) because samples tested positive for Listeria monocytogenes. The product was distributed to California, Texas, and Maryland.
Avid Medical is recalling 130 Adult Chest Tube Trays due to potential contamination from mold growth in a component. The BD ChloraPrep applicator may grow Aspergillus penicillioides, which could breach package integrity and contaminate other kit components.
The Kroger Co. is recalling Chicken Street Taco kits because the Chipotle Crema component contains egg, which is not declared on the product label. This poses a risk to consumers with egg allergies.
Alphatec Spine is recalling the Insignia Anterior Cervical Plate System because the screw blocking mechanism may disassociate during surgery or unlock afterward. Eight units were distributed across 15 states.
Normand Remisol Advance Data Manager versions 1.5–1.9 have insufficient instructions for proper rule programming and testing. User-written rules may not be properly validated, potentially leading to erroneous laboratory results.
Alphatec Spine is recalling the Insignia Anterior Cervical Plate System due to a potential failure in the screw blocking mechanism that may disassociate or unlock during or after surgery.
CooperSurgical has recalled its Wallach Loop Electrodes (Lot 274420) due to incorrect packaging. Packages labeled as Square Electrodes contained Round Electrodes instead, creating a risk of improper device use in surgical procedures.
Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism that could disassociate or unlock during or after surgery.
Quanta System is recalling 307 reusable sterile optical laser fibers nationwide due to potential sterility compromise. The affected devices were distributed through six U.S. distributors.
Cove Appliance is recalling about 42,000 built-in dishwashers because the heating element can fail to shut off and overheat, creating a fire hazard. The company has received five reports of burning smells, flames, and smoking inside the dishwashers, though no injuries have been reported.
Philips is recalling 156 Ingenia Ambition S diagnostic MR systems due to a mechanical issue detected in the lifting blocks on the magnet used during equipment movement and decommissioning.
Alphatec Spine is recalling 7 units of the Atec Insignia Anterior Cervical Plate System because the screw blocking mechanism could disassociate or unlock during or after surgery.
Alphatec Spine is recalling Atec Insignia Anterior Cervical Plate System units due to a potential defect where the screw blocking mechanism may disassociate or unlock during or after surgery. No adverse events have been reported.
Philips has recalled 156 Ingenia Ambition X MRI systems due to a mechanical defect in the hoisting blocks used to move the magnet during decommissioning or relocation. The defect poses a risk that the magnet could fall.
RayStation radiation therapy treatment planning software versions 6 through 10A contain defects that may cause misleading dose evaluations and contouring errors. Healthcare facilities should verify treatment plans and contact the manufacturer for guidance.
Viewray, Inc. is recalling MRIdian Linac System treatment delivery software in French, German, and Italian versions due to software anomalies affecting radiation therapy systems.
Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System due to potential disassociation or postoperative unlock of the screw blocking mechanism during or after cervical spine surgery.
Alphatec Spine's Atec Insignia Anterior Cervical Plate System has a potential defect where the screw blocking mechanism may disassociate during or after surgery, which could compromise spinal stabilization.
Medtronic is recalling Braive Growth Modulation System Break-Off Set Screws due to a thread profile defect caused by a manufacturing issue. The defect may affect proper device function.
Jesmar Spices, LLC is recalling Adobo para Chorizo Seasoning for Sausage because it contains undeclared soy lecithin from chocolate used in the product. The allergen is not listed on the product label.
Alphatec Spine recalls its Atec Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism, which may disassociate or unlock during or after spinal surgery.
Alphatec recalls the Insignia Anterior Cervical Plate System due to risk that the screw blocking mechanism may disassociate during or after surgery.
Alphatec Spine recalls Atec Insignia Anterior Cervical Plate Systems because the screw blocking mechanism may fail during or after surgery. The mechanism may disassociate or unlock, potentially compromising implant stability.
Quanta System is recalling Olympus Sterile Optical Laser Fibers nationwide due to potentially compromised sterility. Approximately 26,925 units distributed through six U.S. distributors are affected.
Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System because the screw blocking mechanism could disassociate or unlock during or after cervical spine surgery.
Brainlab's ExacTrac Dynamic radiotherapy positioning software may delay display of patient movement during high-dose treatments, risking treatment precision errors. 22 systems affected across 11 U.S. states.
Alphatec Spine recalls its Insignia Anterior Cervical Plate System because the screw blocking mechanism may disassociate during spinal surgery or unlock afterward. Healthcare providers should contact the manufacturer for guidance.
Alphatec Spine's Atec Insignia anterior cervical plate system has a defect in the screw blocking mechanism that could disassociate or unlock during or after surgery.
Alphatec Spine Inc. is recalling the Atec Insignia anterior cervical plate system because the screw blocking mechanism may disassociate intraoperatively or unlock postoperatively. No injuries reported.
The Alphatec Insignia anterior cervical plate system may have a defect where the screw blocking mechanism disassociates during surgery or unlocks afterward. Consult your doctor if you have this implant.
Whole Foods Market Organic Dark Red Kidney Beans are being recalled because they contain undeclared allergens: wheat, soy, and milk. Consumers with allergies to these ingredients should not consume the product.
Alphatec Spine is recalling the Insignia Anterior Cervical Plate System due to a potential failure in the screw locking mechanism. The mechanism may disassociate or unlock during or after spinal surgery.
The FDA is recalling certain Atec Insignia Anterior Cervical Plate Systems due to a potential defect in the screw blocking mechanism that could disassociate or unlock during or after surgery.
Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism. The screws may disassociate or unlock during or after surgery, risking implant failure.
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