Archive
576 recalls were announced in November 2021.
Of the 576 recalls this month scored against our rubric, 0% are Critical, 42% are Severe.
Which agencies issued them
Chrysler is recalling 2022 Ram 1500 vehicles because incompatible HVAC systems may render the windshield defrosting and defogging system inoperable, reducing driver visibility.
Siemens Healthcare Diagnostics is recalling 261 ADVIA Centaur SARS-CoV-2 Antigen Assay test kits distributed nationwide because the FDA determined that validation data submitted for emergency authorization was insufficient to confirm the assay's effectiveness.
FujiFilm Arietta 850 ultrasound systems with affected software versions display cardiology measurement results incorrectly. The recall affects 38 units distributed nationwide.
Siemens Healthcare's Aptio Automation Interface Module firmware may incorrectly associate test results with the wrong sample IDs, potentially affecting clinical decision-making.
Implant Direct Sybron Manufacturing is recalling 83 dental implants from lot 166300 because the implants differ in size from what is labeled on the packaging. The implants were distributed across multiple US states and Japan.
Siemens is recalling Atellica IM SARS-CoV-2 Antigen Assay kits because validation data submitted to the FDA was insufficient to confirm the assay's accuracy for its intended use.
Queen Comfort Products is recalling the COVENA PICC Sleeve, marketed without FDA clearance. Patients currently using the device should contact their healthcare provider immediately.
Siemens Artis zeego fluoroscopic X-ray systems have a software error that incorrectly displays 3D image reconstruction when the patient table is rotated more than 4 degrees, potentially resulting in incorrect patient treatment during image-guided procedures.
ABUS is recalling about 790 MountZ youth helmets that do not meet U.S. safety standards for bicycle helmets. The helmets pose a risk of head injury and should be returned for a full refund.
Lupin Pharmaceuticals is recalling Irbesartan 75 mg tablets due to detection of the impurity N-nitrosoirbesartan in the active pharmaceutical ingredient. The recall affects 51,144 bottles distributed nationwide.
3M Red Dot ECG monitoring electrodes (Catalog No. 2244) are being recalled due to potential breakage of the carbon stud from the eyelet. Approximately 2,081,000 units distributed nationwide and internationally are affected.
Picket Fence Creamery is recalling maple ice cream sold in Iowa grocery stores because it contains undeclared soy lecithin, which poses a hazard to consumers with soy allergies.
Craftmark Bakery is recalling Chocolate Chip Cookie Dough (Tiff's Treats brand) due to undeclared tree nut allergen. The product was distributed to 68 retailers through 3 distributors.
GM Helix Acqua Implant dental implants were mislabeled as a smaller size. If incorrectly installed in cases with low bone quality, they could damage the nerve or adjacent bone structures.
Cook Inc. recalls Flexor Check-Flo Introducer Sets where the radiopaque marker band is incorrectly positioned, which may not be discovered until the device is used in a patient under fluoroscopy, increasing procedural time.
Cedar's Organic Mediterranean Hummus 10 oz. is being recalled because it may contain undeclared pine nuts, a tree nut allergen. Consumers with tree nut allergies should not consume this product.
Picket Fence Creamery is recalling Dutch Letter ice cream due to undeclared almonds. The product label declares nuts but does not specify almonds, posing a risk to consumers with almond allergies.
Picket Fence Creamery is recalling Jalapeno-Ranch White Cheddar cheese curds (12 oz, UPC 094922414984) distributed to Iowa grocery stores because they contain undeclared soy lecithin, a potential allergen for consumers with soy allergies.
Picket Fence Creamery L.L.C. is recalling Chocolate Malt ice cream in multiple container sizes distributed to Iowa grocery stores due to undeclared soy lecithin, a potential allergen.
Picket Fence Creamery is recalling Bacon-Ranch White Cheddar cheese curds due to undeclared soy lecithin. The product may pose a risk to consumers with soy allergies.
Mountain View Bakery is recalling Apple White Chocolate Bread (4oz and 8oz sizes) sold at Pilot gas stations in Tennessee because the product contains undeclared milk, a common allergen.
Lakeview Farms is recalling Smilin' Bob's Key West Original Smoked Fish Dip because it contains undeclared egg, a common allergen. The product was distributed in Georgia and Florida.
Karl Storz FIVE S 3.5x65 flexible intubation videoscopes failed sterility assurance testing. The recall affects 532 units distributed across the US and Canada due to infection risk.
Kansas City LLC., operating as Best Harvest Bakeries, is recalling potato buns distributed to restaurants across 14 states due to positive environmental samples detected for Listeria and Salmonella species.
Kansas City LLC, doing business as Best Harvest Bakeries, is recalling hamburger buns distributed to restaurants across 14 states due to positive environmental samples for Listeria and Salmonella species.
Picket Fence Creamery is recalling Chocolate Cherry ice cream sold in Iowa due to undeclared soy lecithin, which poses a risk to consumers with soy allergies.
Picket Fence Creamery is recalling Mocha! ice cream in multiple sizes due to undeclared soy lecithin. Consumers with soy allergies who purchased this product should not consume it.
Mountain View Bakery is recalling Chocolate Cake Rolls (4oz and 8oz) distributed to Pilot gas stations in Tennessee because the product contains undeclared milk, a common allergen.
Picket Fence Creamery is recalling S'mores ice cream in multiple sizes due to undeclared soy lecithin, which poses a risk to consumers with soy allergies.
Picket Fence Creamery is recalling Luscious Lemon ice cream in quarts, pints, and half-pints due to the presence of undeclared soy lecithin. Consumers with soy allergies should not consume the product.
Meijer is recalling Fresh From Meijer Honey Ham & Cheddar Pretzel Roll Sliders because they contain undeclared soy lecithin, which poses a risk to consumers with soy allergies.
Kansas City LLC., doing business as Best Harvest Bakeries, is recalling hamburger buns distributed to restaurants across multiple states due to positive environmental samples for Listeria and Salmonella species.
Green Giant Fresh whole red onions in 2 lb. mesh bags are being recalled due to potential contamination with Salmonella Oranienburg. The affected product was distributed in North Dakota and Minnesota.
Mountain View Bakery is recalling Peaches and Crème Cake (4oz and 8oz) sold at Pilot gas stations in Tennessee because the product contains undeclared milk, a common allergen that poses a serious health risk to consumers with milk allergies.
Picket Fence Creamery is recalling Cow Path ice cream because it contains undeclared peanuts, even though the label only declares nuts in general. Consumers with peanut allergies may be at risk.
Picket Fence Creamery is recalling CowaBrownie! ice cream in multiple sizes due to undeclared soy lecithin. Consumers with soy allergies should not consume this product.
Meijer Inc is recalling Fresh From Meijer Turkey & Provolone Pretzel Roll Sliders due to undeclared soy lecithin. The product may pose a risk to consumers with soy allergies.
Europastry USA INC is recalling frozen onion pockets sold under multiple labels because they may contain Salmonella. Consumers should not eat the affected products.
Picket Fence Creamery is recalling White Chocolate Raspberry ice cream because it contains undeclared soy lecithin, which poses a risk to consumers with soy allergies.
Kansas City LLC., DBA Best Harvest Bakeries is recalling hotdog buns distributed to restaurants across 15 US states due to positive environmental samples for Listeria and Salmonella species.
Kansas City LLC., DBA Best Harvest Bakeries is recalling approximately 10,712 hamburger buns distributed to restaurants across 14 states due to positive environmental samples for Listeria and Salmonella.
Picket Fence Creamery is recalling 12 oz packages of Taco White Cheddar cheese curds due to undeclared wheat and missing gluten-free labeling. The product was distributed to grocery stores in Iowa.
NSE Products, Inc. is recalling Pharmanex Kids Jungamals dietary supplement because the label does not disclose fish allergen present in the product's Vitamin E ingredient.
Picket Fence Creamery is recalling Key Lime Pie ice cream due to undeclared wheat and soy lecithin, and lack of gluten-free labeling. The product was distributed to grocery stores in Iowa.
Kansas City LLC., operating as Best Harvest Bakeries, is recalling hamburger buns distributed to restaurants across 15 states due to positive environmental samples for Listeria and Salmonella species.
Lisendo 880 Ultrasound Software versions V1.0–V4.1.3 may not display cardiac measurement results correctly for mitral valve assessments, affecting diagnostic accuracy.
Implant Direct is recalling 61 dental implants because the packaged implants are a different size than declared on the labeling. Patients who may have received these implants should contact their healthcare provider.
Bayer Medical Care is recalling 6,950 units of MEDRAD Twist & Go Disposable Syringes due to labeling errors that could cause confusion about syringe compatibility with the MEDRAD Mark 7 Arterion Injection System.
FujiFilm Healthcare is recalling Arietta 750 Ultrasound Software versions V1.0.0 through V2.1.3 due to measurement display errors in critical cardiology functions that could lead to incorrect clinical diagnoses. The instruction manual also contains an error.
Arietta 65 Ultrasound systems with software versions 1.0 through 4.0.0 contain a calculation error that produces incorrect measurements of cardiac valve function during diagnostic assessments.
Dr. Reddy's Laboratories is recalling Ezetimibe and Simvastatin 10 mg/10 mg tablets nationwide because the product was manufactured using an excipient that failed to meet conductivity specifications.
Medtronic recalled the Clinician Programmer Application (CPA) model A610 due to a potential software anomaly. Affected versions 3.0.1048, 3.0.1057, 3.0.1062, and 3.0.1081 have been distributed worldwide. No illnesses or injuries have been reported.
Lupin Pharmaceuticals is recalling Irbesartan 300 mg tablets due to the detection of N-nitrosoirbesartan impurity in the active pharmaceutical ingredient. The recall affects approximately 119,544 bottles distributed nationally.
Dr. Reddy's Laboratories is recalling Ezetimibe and Simvastatin Tablets (10 mg/80 mg) because the product was manufactured using an excipient that failed to meet conductivity specifications.
PepsiCo is recalling Starbucks Doubleshot Espresso canned coffee products due to inadequate sealing that may lead to premature spoilage. The recall affects approximately 85,956 cases distributed nationwide.
Ivar's Kettle Classic Clam Chowder with Uncured Bacon is being recalled due to the presence of plastic fragments in the product. The recall affects approximately 14,968 sleeves distributed across thirteen Midwestern states.
Dr. Reddy's Laboratories is recalling 696 bottles of Ezetimibe and Simvastatin Tablets (10 mg/40 mg) distributed nationwide due to failed excipient specifications and the presence of foreign tablets in bottles.
Yang Wu International Inc is recalling Asian Pears (YW Brand, 5Kg cases, Lot YF21008) distributed in California and Pennsylvania after the California Department of Pesticide Regulation found the pesticide Phorate at 0.055 ppm, a level determined to be a health hazard.
Dr. Reddy's Laboratories is recalling Ezetimibe and Simvastatin 10 mg/40 mg tablets because an excipient used in manufacturing failed conductivity specifications. The recall affects 11,590 bottles of 30-count and 3,585 bottles of 90-count packages distributed nationwide.
Picket Fence Creamery L.L.C. is recalling Orange Pineapple ice cream sold in Iowa because it contains undeclared Yellow #6, a color additive that may affect consumers with sensitivity to artificial dyes.
Dr. Reddy's Laboratories is recalling Ezetimibe and Simvastatin Tablets (10 mg/20 mg) nationwide because the product was manufactured using an excipient that failed conductivity specifications.
PepsiCo is recalling Starbucks Doubleshot Espresso and Espresso & Cream canned coffee products because inadequate sealing may cause premature spoilage.
MicroVention's Aspiration Syringe Kit (REF: MVSK60) was labeled for international distribution but inadvertently shipped to U.S. customers. The affected lot (H2146461) was distributed to Alabama, Nevada, and New York.
PepsiCo is recalling Starbucks Doubleshot Espresso and Espresso & Salted Caramel Cream canned coffee products due to inadequate sealing that may lead to premature spoilage.
Cook Inc. is recalling one lot of Flexor Check-Flo Introducers due to a manufacturing defect where the radiopaque marker band may be positioned incorrectly, affecting visualization during medical procedures.
Health & Wellness Center, Inc. is recalling Dr. Berg Nutritionals Liquid Vitamin D with Zinc Dietary Supplement due to mold and yeast levels that exceed product specifications.
Tesla is recalling certain 2021 Model X and Model S vehicles because the driver's air bag cushion may tear during deployment, potentially failing to protect occupants in a crash. Tesla will replace the air bag free of charge.
Autocar is recalling 2019-2022 Xpeditor vehicles because the hazard lights will not function with the ignition turned off. This violates federal safety standards and could increase crash risk in hazard situations.
Keystone RV Company is recalling 2022 Arcadia fifth wheel travel trailers because the Federal Identification Label contains incorrect tire size and pressure information. This could lead to over-inflation and increase the risk of crashes.
2021-2022 Western Star 49X trucks may have improperly installed steering shafts that can separate, causing loss of steering control. Daimler will inspect and repair affected vehicles free of charge.
Isuzu is recalling 2018-2021 FTR and Chevrolet 6500XD trucks because a steering bolt may loosen, causing difficulty steering and increased crash risk.
Kia Motors America is recalling 2020-2021 Stinger vehicles with a fuel gauge software error that may cause inaccurate readings, risking unexpected fuel depletion and vehicle stalling.
Tiffin Motorhomes is recalling certain 2018–2022 recreational vehicles with sofa seat belts that may not be correctly installed. Unsecured passengers face increased injury risk in a crash.
Mercedes-Benz is recalling certain 2021 GLB250 and AMG GLB35 vehicles because the driver-side window airbag may not be properly mounted to the A-pillar, which could prevent proper deployment during a crash.
Yamaha is recalling 2016-2021 FJR1300 motorcycles because a previous software update may prevent the engine from accelerating as intended, increasing crash risk.
Cottrell is recalling 2019-2022 2-Car Carriers because four side-rear reflex reflectors are missing, which reduces visibility and increases crash risk.
Volvo Trucks North America is recalling 2021 VNL vehicles because a machining defect in the power steering pump may cause a loss of steering assist, increasing crash risk.
Kubota is recalling about 48,875 RTV-X1100C utility vehicles from model years 2013 through 2021 because floor mats can warp or degrade and interfere with the throttle pedal, creating crash and injury risks.
Supreme is recalling 2019-2020 Dry Freight Body vehicles because a rearward-aiming license plate light may increase crash risk.
Tracker Marine is recalling 2022 Ranger Trail boat trailers because improperly spaced fenders may contact tires, causing premature wear and potential tire failure.
Backyard Play Systems is recalling four outdoor playset models due to an entrapment hazard in the wooden roof design. Children can become trapped in gaps between the roof structure and gable decoration.
ROSA One 3.1 surgical guidance system recalled due to a software anomaly causing inaccurate electrode placement during brain and spine surgery. Manufacturer received 3 complaints related to the issue.
Red Mountain Compounding Pharmacy is recalling methylcobalamin 1000 mcg/mL injectable due to FDA inspection findings that raised concerns about the product's sterility assurance.
Red Mountain Compounding Pharmacy is recalling a compounded anabolic steroid product due to FDA concerns about sterility assurance identified during inspection. The product was distributed to approximately 494 patients in seven states.
Red Mountain Compounding Pharmacy is recalling Cyclosporine 2% MCT Oil Suspension due to FDA inspection findings of sterility assurance concerns. Approximately 494 patients in seven states received prescriptions for this medication.
Red Mountain Compounding Pharmacy is recalling Levocarnitine 100mg/mL solution for injection because FDA inspection found concerns about the product's sterility assurance. The product was distributed to patients in seven states.
Red Mountain Compounding Pharmacy is recalling Estradiol Valerate 5mg/mL injectable medication due to FDA inspection findings of inadequate sterility assurance. The product was distributed to approximately 494 patients across seven states.
Red Mountain Compounding Pharmacy is recalling an ascorbic/glutathione eye solution because FDA inspection identified concerns about sterility assurance during manufacturing.
Red Mountain Compounding Pharmacy is recalling Ascorbic Acid (Non-Corn) 500mg/mL Solution for Injection due to lack of assured sterility identified during an FDA inspection. The affected product was distributed to approximately 494 patients in seven states.
Red Mountain Compounding Pharmacy is recalling methylcobalamin 10,000 MCG/ML multi-dose vials after FDA inspection identified sterility assurance concerns.
Kwokcheng Enterprise, Inc. dba Fullei Fresh is voluntarily recalling all lots of refrigerated bean and soy sprouts distributed in Florida due to potential Listeria monocytogenes contamination.
Nestle USA is recalling Nature's Heart Pineapple Chili Cashew Glazed Mix due to undeclared peanut allergen. The product was distributed across 32 states, and consumers with peanut allergies should not consume it.
Nestle USA is recalling Nature's Heart Toasted Coconut Chips 1.5oz pouches because they contain undeclared peanuts, posing a serious risk to consumers with peanut allergies.
Schlotterbeck & Foss LLC is recalling Simply Nature Organic Poppy Seed Dressing because the product may not be adequately acidified, which could allow growth of harmful bacteria.
Nestle USA Inc. is recalling Nature's Heart Mango Turmeric Cashew Glazed Mix 1.5oz pouches due to undeclared peanut allergen. The product was distributed across 32 states.
Red Mountain Compounding Pharmacy is recalling Glutathione 200mg/mL MDV (multiple-dose vials) because FDA inspection identified concerns that the product may lack proper sterility assurance. The product was distributed to patients in multiple states.
Nestle USA is recalling Nature's Heart Superfood Trail Mix 1.5oz pouches because they contain undeclared peanuts, posing a serious risk to consumers with peanut allergies.
Daimler Vans USA is recalling one 2020 Mercedes-Benz Sprinter because incorrect-size front brake discs may extend stopping distance and increase crash risk.
Red Mountain Compounding Pharmacy is recalling Test Cypionate 100MG/ML in Ethyl Oleate Oil due to FDA inspection findings of sterility assurance concerns.
Red Mountain Compounding Pharmacy is recalling TEST CYP/PROP 160/40MG/ML MDV in ethyl oleate due to FDA inspection findings that raised concerns about sterility assurance. Approximately 494 patients in multiple states received affected prescriptions.
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