Archive
771 recalls were announced in June 2021.
Of the 771 recalls this month scored against our rubric, 1% are Critical, 14% are Severe.
Which agencies issued them
Medtronic is recalling specific lots of BB11J14R2 Bridge Custom Perfusion System tubing packs due to incomplete or insufficient welds that may have occurred during manufacturing.
Anodyne Surgical has recalled hydrodissection cannulas due to a possible yellowish-brown or greenish-brown residue on the tip. The affected devices were distributed in multiple US states and Canada.
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 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.
Radiometer Medical ApS is recalling ABL90 FLEX Analyzers with E3800 PC units due to an internal clock issue. Approximately 3,346 units are affected globally, with only 2 in the United States.
Hix Sauces Buffalo Wing Sauce is being recalled because the product label declares butter but does not list milk as an ingredient, creating an allergen risk for consumers with milk allergies.
The Better-Bladder ECMO device used in cardiopulmonary bypass circuits may collapse during use, increasing venous line resistance and reducing blood flow. The recall affects 147 units distributed nationwide.
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.
Bard Peripheral Vascular recalls VENOVO Venous Stent System 9F due to reports that the proximal end fails to expand immediately upon deployment and remains connected to the delivery system.
GE Healthcare interventional x-ray imaging systems can develop a display defect that splits and distorts live monitor images into two unequal parts. The defect affects 139 devices with worldwide distribution.
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.
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 BB10R94R6 Custom Perfusion System tubing packs due to incomplete or insufficient welds. The defect may affect device performance during use.
Medtronic is recalling specific lots of BB8M63R5 adult cardiac perfusion tubing packs due to incomplete welds in the manufacturing process. These defects could compromise tubing integrity during cardiac surgery.
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 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.
Medivators, Inc. recalls 1,381 cases of dialysate concentrate due to a manufacturing anomaly that may result in out-of-specification formulation. Affected lots may not function properly in hemodialysis treatment.
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 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 18 tubing packs used in perfusion systems due to potentially incomplete or insufficient welds that may compromise device integrity. No injuries have been reported.
Natural Foods Inc is recalling BulkFoods.com brand Basic Vegetable Starter products due to potential Salmonella contamination in the celery ingredient. The recall affects 1lb and 5lb bags and 20lb boxes distributed across 23 US states.
Abbott's WorkMate Claris cardiac monitoring system (Model H700124) is being recalled due to a software error that may disable the system or turn the screen black. Nine units affected in Michigan, Kansas, Missouri, and Texas.
Nissan is recalling certain 2020-2021 Versa, Titan, and Titan XD vehicles because the front turn signal bulbs can crack and fail to illuminate, increasing the risk of crashes.
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.
Lamborghini is recalling 2018-2021 Huracan vehicles because the rearview camera may fail to display in cold temperatures, increasing crash risk.
Covidien, LP is recalling a mechanical respiratory filter (Item 351/5979) due to potential deviations in ethylene oxide sterilization. The product was distributed worldwide and in multiple U.S. states.
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.
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.
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.
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.
Dr. Reddy's Laboratories is recalling Atorvastatin Calcium Tablets USP 10 mg nationwide because certain lots contain impurities that exceeded acceptable specifications.
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.
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.
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.
Trailstar is recalling 2017-2019 Dump Trailers because the steering arm may detach, potentially causing loss of steering control or road hazards.
KZRV is recalling 2021 Connect travel trailers because low tongue weight may cause instability at highway speeds, increasing crash risk.
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.
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.
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.
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.
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.
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.
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.
Sealight is recalling S1H11 LED headlight bulbs that create excessive glare, failing federal safety standards and increasing crash risk.
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.
Temsa is recalling 2014-2020 TS45 buses because a rusted wire on the roof emergency exit handle may break, delaying evacuation.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Alphatec Insignia Anterior Cervical Plate System screw blocking mechanism may disassociate during surgery or unlock afterward. No injuries reported.
Wishbone Medical is recalling WishBone Medical Plate and Screw System implants due to nonconformities in engineering specifications. The recall affects 60 units distributed in Virginia, Pennsylvania, and Indiana.
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.
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.
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.
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.
DePuy Orthopaedics recalled 50 hip prostheses with incorrect part numbers and sizes etched on the devices. The affected Lot D20111130 was distributed domestically and to Bermuda.
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 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.
The Alphatec Insignia Anterior Cervical Plate System is recalled because the screw blocking mechanism may disassociate intraoperatively or unlock postoperatively. Eight units were distributed across 15 U.S. states.
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.
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.
Alphatec is recalling its Insignia Anterior Cervical Plate System due to potential screw blocking mechanism failure during or after spinal surgery. The screw may disassociate intraoperatively or unlock postoperatively.
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 recalled the Atec Insignia Anterior Cervical Plate System due to potential failure of the screw blocking mechanism, which could disassociate during or after surgery.
Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System because the screw blocking mechanism may disassociate or unlock during or after spine surgery, potentially compromising implant stability.
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.
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.
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.
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.
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.
Nico Corp. is recalling 80 Myriad-LX Light Source units due to potential burn injury to patients from the distal tip of the fiber assembly and risk of delivery sleeve occlusion during surgical use.
Alphatec Spine is recalling the Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism that could disassociate or unlock during or after surgery.
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.
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.
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.
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 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.
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