Agency
The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.
Orthalign, Inc is recalling Drill Plate components for the Lantern Knee System due to manufacturing defects that can cause excessive bone cuts during orthopedic surgery.
I.T.S. GmbH is recalling 623 units of HCS Headless Compression Screws nationwide due to RF-induced temperature increases during MRI procedures that exceed what was documented in the product instructions.
Tandem insulin pumps in Czech Republic and Slovakia are recalled for translation errors. An error tells users to verify infusion set connection when it should state not connected, risking unintended insulin delivery and hypoglycemia.
Olympus Endoscope Reprocessor OER-Elite is no longer compatible with MAJ-1443 and MAJ-1444 endoscope models. Affected endoscopes may not be properly sterilized when processed in this reprocessor, creating infection risk.
I.T.S. LRS surgical implants are recalled because updated MRI testing shows higher temperature increases than documented in labeling. 176 units affected nationwide.
Beckman Coulter is recalling 685 boxes of MicroScan Neg MIC 56 diagnostic panels due to likely presence of contamination in test wells. The affected lot was distributed across 12 U.S. states.
Lidl US is recalling Favorina Chocolate Ladybugs German-Style Nougat because the label does not specify which tree nut is contained in the product, posing a risk to consumers with tree nut allergies.
King Harvest brand Roasted Red Pepper Hummus is being recalled due to the presence of aluminum pieces in the product. The affected hummus was distributed in Oregon and Washington.
American Laboratories is recalling Pepsin Full Strength Powder (50 kg drums/boxes, Item #5000545) due to potential Salmonella contamination. The product was distributed to wholesale accounts in multiple US states and Australia.
Ajinomoto Foods North America Inc. is recalling Trader Joe's Vegetable Fried Rice (1 lb bags, Item 5650233) due to glass fragments (1–3 cm long, 2–4 mm wide) found in the product. The recall affects approximately 9.9 million pounds distributed across 40 US states.
Ajinomoto Foods North America Inc. is recalling Ajinomoto Vegetable Gyoza Dumplings due to the presence of glass fragments in the product. The recalled dumplings were distributed nationwide.
Sevillo Fine Foods is recalling Slow Roasted Diced Tomatoes (SKU 900, UPC 00823338009008) because the product may contain metal fragments.
Tops GOLD Lime Pickle, a 31.74 oz product from Mangalm LLC, is recalled due to potential adulteration with erucic acid from mustard oil. The recall affects products distributed in CA, NV, OR, UT, and WA.
American Laboratories is recalling Pepsin 1:10,000 Powder (10 kg, Item #FTI-G0193-00, Lot Code 00560021) distributed to wholesale accounts due to potential Salmonella contamination.
NRS Enterprises, Inc. dba Sunflour Bakery is recalling 18oz packages of Sunflour Bakery Hamburger Buns (UPC 832971001522) because they contain undeclared sesame seed, a potential allergen.
South Florida Food, LLC is recalling Pan de Bono (Cheese Bread) because the product contains undeclared soy, a common allergen that poses a health risk to consumers with soy allergies.
Ajinomoto Foods North America Inc. is recalling Kroger Chinese Inspiration Vegetable Fried Rice due to the presence of glass fragments varying from 1–3 cm long and 2–4 mm wide.
Western Mixers Produce & Nuts, Inc. is recalling Treasured Harvest brand Chilli Spanish Peanuts (25lb bags, Lot #260230) due to glass fragments found in sealed containers.
American Laboratories is recalling Pepsin 1:3000 Powder (50 kg, Item #FTI-G0193-00) due to potential Salmonella contamination. The product was distributed to wholesale accounts in multiple states and Australia.
Savannah Bee Company is recalling Honey BBQ Sauce Mustard bottles containing an undeclared different flavor product with soy and wheat allergens not listed on the label.
Medtronic MiniMed 780G insulin pumps with software versions 6.60, 6.61, and 6.62 may have three software defects causing inaccurate insulin delivery, risking hypoglycemia or hyperglycemia.
Pacific Coast Fresh CO is recalling King Harvest brand Spinach Hummus (10 oz containers) due to the presence of aluminum pieces in the product. Consumers should not consume the product and should return or discard it.
Nuts.com is recalling Espresso Malted Milk Balls sold in 1 lb. and 20 lb. packages because the labels do not declare wheat and soy allergens that are present in the product.
Distribuidora de Alimentos Sendero LLC is recalling Doraditas de Azucar because the product label is missing declarations for wheat and soy allergens.
Ajinomoto Foods North America Inc. is recalling Ajinomoto Green Gyoza Vegetable & Edamame Dumplings due to the presence of glass fragments (1–3 cm long and 2–4 mm wide) in the product.