Archive
456 recalls were announced in November 2022.
Of the 456 recalls this month scored against our rubric, 2% are Critical, 22% are Severe.
Which agencies issued them
Navistar is recalling 2022-2023 IC EV school buses because high-voltage cables may be mislabeled, increasing the risk of electrical shock for technicians.
ScentLok is recalling OZ OZ20 vehicle deodorizers because they may overheat, increasing the risk of a fire. Owners will receive free replacements.
Navistar is recalling certain 2021-2023 International MV vehicles due to mislabeled high-voltage battery cables that could be mistaken for de-energized cables, risking electrical shock to technicians or first responders.
Viatris Inc is recalling Octreotide Acetate Injection due to glass particles found in syringes. Approximately 22,400 syringes of lot #AJ21002 (expiration 03/2024) were distributed nationwide.
Sotto i Trulli is recalling Bombolo Biscotti Assorted Italian Cookies due to undeclared walnut allergen. Consumers with walnut allergies should not consume this product.
Boston Scientific recalls ORISE ProKnife Procedure Kits due to higher incidence of foreign body reactions to remnant gel post-procedure, which have required surgical intervention in affected patients.
DA CHENG VEGETARIAN FOOD INC. recalls Vegan Golden Nuggets due to undeclared egg allergen. The product is marketed as vegan but contains egg, which is not declared on the label.
Whole Foods Market Dipping Caramel (PLU 34888) is recalled because it contains wheat that was not declared on the label. Consumers with wheat allergies should not consume this product.
DA CHENG VEGETARIAN FOOD INC. recalls Vegan Golden Nuggets for containing undeclared egg. The product was distributed to restaurants and retail stores in Utah, Virginia, Texas, and California.
Boston Scientific has recalled ORISE Gel Syringe kits used in gastrointestinal endoscopy due to higher incidence of foreign body reactions from remnant gel requiring surgical intervention.
Boston Scientific is recalling ORISE Gel Submucosal Lifting Agent due to higher incidence of foreign body reactions to retained gel. These reactions caused mass formations requiring surgical intervention.
DA CHENG VEGETARIAN FOOD INC. is recalling Vegan Drumsticks because they contain egg that is not declared on the label. The product poses a risk to consumers with egg allergies.
ReadyMeals Chicken Salad Quad products distributed in CO, NE, NM, SD, and WY have labels missing tree nut (cashew) allergen information. Consumers with tree nut allergies should not consume this product.
Hammond's Salted Caramel Cookies contain an undeclared peanut allergen due to mispacking of Peanut Butter Chocolate Chip Cookies into Salted Caramel boxes. Nationwide distribution affected.
Tyson Fresh Meats is recalling raw ground beef products in Texas that may contain reflective mirror-like material. No illnesses have been reported.
Bakkavor USA is recalling H-E-B Meal Simple Tomato Basil Soup due to an undeclared milk allergen that poses a risk to consumers with milk allergies.
CooperSurgical is recalling NEO-fit Neonatal Endotracheal Tube Grips due to metal clips that can become loose or detach. Eleven complaints include three cases of clip ingestion, three removals from the mouth, and one throat laceration.
Albertsons Companies LLC is recalling Chicken Salad Sandwich Club trays because labels fail to disclose tree nuts (cashews) in the ingredient and contains statements. Consumers with cashew allergies may unknowingly consume these sandwiches.
Canon Aplio ultrasound systems may fail to properly terminate the Stress Echo protocol, potentially causing patient images to be assigned to wrong patients or not saved. This could delay diagnosis and treatment.
Shyft Group is recalling 2022 Utilimaster Aeromaster vehicles because the side-view image may display the wrong side of the vehicle when the turn signal and brake are applied simultaneously.
Taylor Farms Retail is recalling BabyBel Snacker cheese products due to undeclared milk and almond allergens on the ingredient label. Consumers with allergies to these ingredients should not consume the product.
MiniMed 600 series insulin pumps have a cybersecurity vulnerability that could allow unauthorized access, potentially resulting in delivery of too much or too little insulin. Users should disable the Remote Bolus feature.
RIVER CITY SEAFOOD INTERNATIONAL LLC is recalling 51 cases of La Rosa Brand BluCrab Pasteurized Crabmeat (lot #0531, best by 11/2023) due to defective seals that could allow contamination.
JLM Sunflower Meat Roasted/Salted is recalled for undeclared cashew allergen affecting 175 cases across 18 states. Consumers with tree nut allergies should not consume.
Avanos Medical is recalling sterile extension sets distributed without expiration dates. Without proper dating, healthcare providers cannot verify sterility assurance, creating a potential patient safety risk.
Access Vascular recalls 79 HydroPICC catheter kits because included scalpel and StatLock components have earlier expiration dates than stated on the package.
Cardinal Health is recalling 409,738 reusable gel pack units because they should not be used on infants or neonates. The company is adding a caution statement to labeling.
Cardinal Health is recalling approximately 414,194 units of its insulated gel pack because the product should not be used on infants or neonates. The company will update product labeling with a clear warning.
X-NAV Technologies is recalling the X-Guide X-Mark Probe Tool because a critical weld may be missing, potentially allowing the probe tip to detach and fall into a patient's mouth during use, creating a risk of aspiration or swallowing.
Cardinal Health is recalling its insulated gel pack because it should not be used on infants or neonates. The product labeling will be updated with a caution statement.
Cardinal Health recalls approximately 649,213 insulated gel packs due to contraindication for infants and neonates. Labeling will be revised with a caution statement.
Cardinal Health is recalling approximately 1.9 million reusable gel packs (Cat. 61115) because the product should not be used on infants or neonates. A caution statement is being added to the product labeling.
Cardinal Health is restricting use of 567,475 reusable hot and cold gel packs (Model M) on infants and neonates due to thermal injury risk. Updated labeling will warn against use on this vulnerable population.
Cardinal Health is recalling 1,209,260 INSULATED GEL PACK REUSABLE, LARGE units because the product is not safe for infants or neonates. The company is adding a warning label.
iRhythm Technologies is recalling clinical reference materials for the Zio AT cardiac monitoring system due to labeling deficiencies that may delay notification of arrhythmias to healthcare providers. Transmission limits could prevent critical cardiac event reporting.
JLM Manufacturing LLC is recalling JLM Sesame Sticks Mix (11oz tubs) because units may contain undeclared cashew, a common allergen. The recall affects 307 cases distributed across 18 states.
Rieckhoff Family Businesses is recalling Gourmet Old-Fashioned Caramel Holiday Popcorn boxes because the label falsely claims the product is gluten-free, though it contains wheat and barley.
Rama Food Manufacture Corp is recalling Pad Thai Noodles (lot 1128A1, manufactured 09/26/22) due to improper cooling and refrigeration during manufacturing. The products may pose a health risk.
Medtronic is recalling MiniMed 630G and 670G insulin pumps due to a cybersecurity vulnerability that could allow unauthorized access to the pump system, potentially resulting in incorrect insulin delivery.
Beaver Arthro-Lok surgical blades may have been configured to curve right instead of left. If used during surgery, the incorrect curve could cause unintended tissue damage.
Sedecal Soltus battery mobile x-ray systems may move without operator command. The FDA is recalling 155 units distributed across the U.S. due to this safety hazard.
Ferno-Washington is recalling 1,922 FERNO POWER X1 ambulance cots with 36V Li-Ion batteries that may become unstable and pose a fire or burn injury risk if dropped, power washed, or abused.
Cardinal Health Reusable Gel Packs are being recalled because they are unsafe for use on infants or neonates. The company will add a warning label stating the product is not for use on infants.
Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate (dialysis product) due to incorrect labeling. The label misidentifies 5.62g/L as potassium chloride when it actually represents calcium chloride, though the product itself is potassium-free.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Calibrator Kit 9 due to incorrect calibration software (DRVs 6194-6200) that prevents laboratory systems from successfully calibrating, causing delayed test results.
Alphatec Spine, Inc. is recalling 42 disc preparation surgical instruments due to manufacturing modifications that lacked proper regulatory clearance. The recall is limited to California.
Shemshad Food Products, Inc. is recalling Pomegranate Fruit Roll Ups due to sodium content measured at 131% of the declared level. The product was distributed to 8 retail locations in the Los Angeles area.
Nova Bus is recalling 2018-2022 LFS and 2018-2021 LFS Artic buses because steering fasteners may loosen, causing loss of steering and increasing crash risk.
Ford is recalling 2021-2022 F-150 vehicles because the front windshield wiper motor may fail, reducing visibility and increasing crash risk.
Volvo Bus is recalling 2023 9700 vehicles because incorrectly installed emergency light sensors may prevent lights from activating after a rollover.
Tesla is recalling certain 2023 Model 3 and 2020-2023 Model Y vehicles because taillights may intermittently fail to illuminate. A failed taillight reduces vehicle visibility and increases crash risk; Tesla is providing a free over-the-air software update.
Tesla is recalling certain 2021-2023 Model X vehicles because a software calibration error in the restraint control module may prevent the front passenger airbag from deploying correctly during crashes, increasing injury risk.
Daimler Trucks North America is recalling 2021-2023 Thomas Built Buses Minotour school buses because the forward seat barrier may not provide sufficient protection, increasing injury risk in a crash.
Kia is recalling 2017-2018 Niro hybrid vehicles because a faulty relay may cause rear seats to overheat, increasing the risk of a fire.
Indian is recalling 2021-2022 Scout and Chief motorcycles for fuel pump failure that may cause engine stall while riding. Dealers will replace the fuel pump and seal free of charge.
Subaru is recalling 2009-2013 Forester vehicles because the front seat belt force-limiter may not operate correctly in a crash, increasing injury risk.
Shyft Group is recalling 2022 Utilimaster Walk-In vans because the catalytic converter cover may damage brake lines, increasing crash risk.
Generac and DR 6500- and 8000-watt portable generators are being recalled because an unlocked handle can pinch and amputate fingers. The firm has received 37 injury reports, including 24 finger amputations.
Navistar is recalling 2023 International MV vehicles because locking clips on the wheel hub retaining nut may be damaged, causing the wheel hub to loosen and separate from the axle housing, which increases crash risk.
Mockingbird Single-to-Double Strollers may have cracks in the frame that pose a fall risk to children. The manufacturer has received 138 reports of frame cracks, including 8 injuries, and is offering free frame reinforcement kits.
Toyota is recalling specific front seat belt assemblies sold as replacement parts because the force-limiter may not operate correctly, increasing injury risk in a crash.
RAM is recalling certain 2500 and 3500 vehicles due to transmission fluid leaks that could cause fires. Dealers will replace the affected components at no cost.
Hunter Fan Company is recalling approximately 2,600 light fixtures from five collections because internal wires can become damaged, posing an electric shock hazard. Consumers should stop using the products immediately and contact Hunter for a full refund.
Old Europe Cheese, Inc. is recalling multiple brands of herb-flavored Brie cheese due to potential contamination with Listeria monocytogenes. Affected products have best-by dates ranging from September 28 to December 14, 2022.
Old Europe Cheese, Inc. is recalling multiple brands of triple creme brie cheese due to potential contamination with Listeria monocytogenes. The recall affects products distributed across the United States and Mexico.
The CritiCool thermoregulation device may experience premature pump failure leading to a HALT 4 error from which the device cannot recover, potentially delaying treatment. One death has been reported.
Old Europe Cheese, Inc. is recalling Reny Picot Fig Baked Brie due to potential Listeria monocytogenes contamination. Affected products with Best By dates from September 28 to December 14, 2022 were distributed across multiple U.S. states and Mexico.
Hillrom Centrella Hospital Beds with WatchCare systems may emit radio frequency signals that interfere with other medical devices. Approximately 6,407 units are affected and distributed in the US.
Old Europe Cheese is recalling Reny Picot and ST Randeaux double-crème Brie cheeses due to potential Listeria monocytogenes contamination. Affected products have best-by dates from September 28, 2022 to December 14, 2022.
Mariscos Bahia Inc is recalling fresh salmon fillet portions distributed to restaurants in Arizona and California due to possible Salmonella contamination. Approximately 179,002 pounds of product have been recalled.
Baxter Healthcare recalls the Hillrom WatchCare Incontinence Management System (63 units in US) because radio frequency emissions from the device may interfere with other medical equipment including infusion pumps and insulin pumps.
Old Europe Cheese is recalling LA BONNE VIE and Reny Picot brand Cranberry Baked Brie cheese due to potential Listeria monocytogenes contamination.
Baxter Healthcare is recalling 129 units of the Hillrom WatchCare incontinence management system due to radio frequency emissions that may interfere with other hospital medical devices such as telemetry units, fetal monitors, and insulin pumps.
Mariscos Bahia Inc recalls halibut fillets and portions due to possible salmonella contamination. Affected product was distributed to 179 restaurant customers in Arizona and California.
Mariscos Bahia Inc is recalling tuna fillets and loins due to possible salmonella contamination. The product was distributed to restaurants in Arizona and California.
Multiple brands of baked brie cheese are being recalled due to potential Listeria monocytogenes contamination. Products were distributed across multiple U.S. states and Mexico.
Old Europe Cheese is recalling TASTE OF INSPIRATION 8 oz Brie cheese rounds due to potential Listeria monocytogenes contamination. The product was distributed across multiple states and Mexico.
Diana's Milk Chocolate Banana Babies are recalled due to undeclared peanut allergen. About 18,468 retail units distributed in UT, MI, IA, WA, and CA are affected.
Old Europe Cheese is recalling Joan of Arc 2.2 lb peppercorn wheel cheese due to potential Listeria monocytogenes contamination. Affected products have best-by dates from September 28 to December 14, 2022.
Saint Louis Brie and related brie products have been recalled due to potential contamination with Listeria monocytogenes. The recall affects 2,701 cases distributed to retailers in Louisiana, Maine, Missouri, North Carolina, and New York.
Mariscos Bahia Inc is recalling swordfish products distributed to restaurants and food service businesses in Arizona and California due to possible salmonella contamination.
Mariscos Bahia Inc is recalling Chilean Seabass fillets and portions due to possible salmonella contamination. The product was distributed to restaurants in Arizona and California.
Old Europe Cheese Inc. is recalling multiple brands of soft cheeses (Brie and Camembert) due to potential Listeria monocytogenes contamination. Affected products were distributed to multiple U.S. states and Mexico with best-by dates from September to December 2022.
Mariscos Bahia Inc is recalling fresh salmon fillets due to possible salmonella contamination. The product was distributed to restaurants in Arizona and California.
Whole Foods Market is recalling Zerto Fontal Cheese due to undeclared egg allergen from egg lysozyme. Products were sold in Connecticut, New Jersey, and New York from September 7-29, 2022.
Baxter Healthcare is recalling the Hillrom WatchCare Incontinence Management System due to radio frequency emissions that may interfere with other critical medical devices including insulin pumps and fetal monitors.
Baxter Healthcare recalls the Hillrom WatchCare Incontinence Management System for Progressa Bed due to potential radio frequency emissions that may interfere with other medical devices including telemetry monitors and infusion pumps.
Mariscos Bahia Inc is recalling Fresh Salmon Deep Skin Fillets due to possible salmonella contamination. The affected product was distributed to restaurants in Arizona and California.
Menu19 LLC is recalling approximately 5,001 pounds of frozen beef dumplings because they were produced without the benefit of federal inspection. The products were shipped to California locations.
Old Europe Cheese, Inc. is recalling Reny Picot Apple Baked Brie due to potential Listeria monocytogenes contamination. The recall affects 1,309 pieces with best-by dates from September 28, 2022 to December 14, 2022.
SenTec AG voluntarily recalled 17,208 units of transcutaneous CO2/O2 monitor attachment rings due to weak skin adhesion. The devices, used in noninvasive patient monitoring, were distributed nationwide.
Boston Scientific is recalling 7 EMBLEM S-ICD Model A209 subcutaneous defibrillators due to a software defect that displays inaccurate battery capacity information. Patients may not realize when their device's battery requires replacement.
Edwards Lifesciences is recalling 715,620 Fogarty Arterial Embolectomy Catheters due to confirmed latex deterioration in the pouch packaging. The material degradation could affect device performance during use.
Medline Industries is recalling 800 Bausch + Lomb Basic Ophthalmic surgical kits (Lot 22DBN365) for defective breather pouch seals. Opened seals in the packaging compromise the sterile conditions required for surgical procedures.
Medline has recalled Bausch + Lomb cataract surgical kits due to breather pouches with seal openings that could compromise sterility. Affected kits were distributed nationwide.
Boston Scientific is recalling 16 EKOS Control Unit 4.0 consoles that were shipped without proper instructions for use or with incorrect instructions, creating risk of improper device operation.
MICROVENTION is recalling WEB Detachment Controllers due to an out-of-specification tunnel opening that may prevent proper implant detachment. This defect could delay treatment and cause vessel damage from implant manipulation.
Medline is recalling approximately 160 surgical kits with defective breather pouches showing seal openings, potentially compromising sterility. The recall affects facilities in eight states nationwide.
Medline recalls Bausch + Lomb Eye surgical kits due to breather pouches with openings in the seal. Affected kits were distributed to healthcare facilities nationwide; unopened kits should not be used.
Becton Dickinson is recalling BD Trucount Tubes due to partial label detachment that can cause tubes to stick together in pouches or fail when used with automated loaders. No illnesses have been reported.
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