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.
The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.
FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.
Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.
Carwild Corporation recalls 300 Ivalon cellulose surgical spears (Model Q604237) due to potential package seal defects that could compromise sterility during ophthalmic surgical procedures.
Gracie's Kitchens Inc. is recalling Tropical Delight Bowls distributed in Connecticut and New York due to potential Listeria monocytogenes contamination. Affected products have sell-by dates of November 11–21, 2024.
Medline custom procedure kits containing non-sterile Codman Surgical Patties & Strips are being recalled due to potential endotoxin contamination. The recall affects 74 units distributed in the US, UAE, and Canada.
King Kullen brand Papaya Chunks are being recalled due to potential Listeria monocytogenes contamination. Consumers should not consume the affected product.
Reser's Fine Foods is recalling Beef & Lamb Gyro Sandwich Express Meal Kits due to potential Salmonella contamination in the tzatziki sauce. The recall affects 5,271 cases distributed across 19 states.
Multiple mango brands sold in Connecticut and New York are being recalled due to potential Listeria monocytogenes contamination. Consumers should discard affected products or return them to retailers.
Gracie's Kitchens Inc. is recalling Wild by Nature and Gracie's Kitchen brand Fruit Spears due to potential Listeria monocytogenes contamination. Affected products were distributed in Connecticut and New York with sell-by dates from November 11 to November 21, 2024.
Gracie's Kitchen brand Broccoli & Cauliflower Florets (12 oz foam trays) are being recalled due to potential Listeria monocytogenes contamination. The recalled products were distributed in Connecticut and New York.
Minnesota Milk Bank for Babies is recalling 136 bottles of pasteurized donor human milk due to potential contamination with undetermined foreign material. The affected batch (002237-1) expires 01/01/2025.
Gracie's Kitchens Inc. is recalling three brands of Fiesta Bowl salads (King Kullen, Wild By Nature, and Gracie's Kitchen) sold in Connecticut and New York due to potential Listeria monocytogenes contamination.
Lithuanian Bakery, Inc. is recalling Chocolate Raspberry baked goods in three sizes due to undeclared milk, soy, peanut, wheat, sulfites, and color dyes. Consumers with allergies should not consume these products.
Gracie's Kitchen brand Mango & Blueberry Cup may be contaminated with Listeria monocytogenes. The recall affects 3,681 cases distributed in Connecticut and New York.
Medline is recalling 943 custom surgical kits containing non-sterile Codman Surgical Patties and Strips that may be contaminated with endotoxin.
Medline Industries is recalling See DocMan custom convenience kits that contain non-sterile Codman Surgical Patties and Strips with potential endotoxin contamination. Approximately 48,655 units were distributed worldwide.
Multiple brands of peppers & onions products are being recalled due to potential Listeria monocytogenes contamination. Affected products were distributed in Connecticut and New York.
Carwild is recalling Ivalon Anatomical Nasal Packing devices because the package seal may be defective, leaving the sterile barrier unable to be guaranteed. Lot 24F1638 with approximately 140 units was distributed across multiple U.S. states and internationally.
Gracie's Kitchens Inc. is recalling King Kullen and Gracie's Kitchen brand Fajita Mix products distributed in Connecticut and New York due to potential Listeria monocytogenes contamination.
Medline is recalling custom surgical procedure kits that contain non-sterile surgical supplies with potential for endotoxin contamination. The kits were distributed worldwide, including the United States, United Arab Emirates, and Canada.
Gracie's Kitchens Inc. is recalling cantaloupe slices and chunks sold under King Kullen, Wild By Nature, and Gracie's Kitchen brands due to potential Listeria monocytogenes contamination. Products were distributed in Connecticut and New York.
Gracie's Kitchens Inc. is recalling diced white onion products due to potential Listeria monocytogenes contamination. Multiple brands (King Kullen, Wild By Nature, Gracie's Kitchen) are affected; products were distributed in Connecticut and New York.
Carwild Corporation is recalling Ivalon Eye Wick 20cm surgical devices due to package seals that are out of specification and cannot guarantee sterile barrier integrity for the life of the product.
Fruit Platters sold under King Kullen and Gracie's Kitchen brands may contain Listeria monocytogenes. Consumers in Connecticut and New York who purchased products with November 11-21, 2024 sell-by dates should not eat them.
Gracie's Kitchen brand Broccoli Florets are being recalled due to possible contamination with Listeria monocytogenes. The recall affects 3,681 cases distributed in Connecticut and New York with sell-by dates between November 14-24, 2024.
Three brands of Halo Bowl (King Kullen, Wild by Nature, Gracie's Kitchen) are recalled for potential Listeria monocytogenes contamination. Affected products sold in CT and NY with Sell By dates 11/11–11/21/24.
Hikma Injectables is recalling phenylephrine injections nationwide because tamper-evident seals on some syringes were not properly attached. Affected lot 243120003D has a use-by date of 03/11/2025.