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.
Gills Onions is recalling fresh slivered yellow onions due to potential Salmonella Thompson contamination. Products were distributed throughout the United States and Canada.
Cross Valley Farms diced yellow onions in specified lot codes are recalled due to potential Salmonella Thompson contamination. Consumers should discard the product or return it to the retailer.
Gills Onions is recalling Imperial Fresh slivered yellow onions due to potential Salmonella Thompson contamination. The product was distributed across 31 U.S. states and five Canadian provinces.
Gills Onions is recalling 1/5 pound containers of fresh diced yellow onions due to potential Salmonella Thompson contamination. The product was distributed across multiple U.S. states and Canadian provinces.
Gills Onions is recalling Imperial Fresh slivered yellow onions due to potential Salmonella Thompson contamination. The recall affects products distributed across the US and Canada.
Kula Brands is recalling Piña Colada + Kratom Seltzer because it contains undeclared milk and coconut allergens and unapproved kratom. Affected consumers should not consume the product.
Pfizer Inc. is recalling 21,390 vials of Lidocaine Hydrochloride 1% injection due to presence of glass particulate matter. Lot 42290DK with expiration 6/1/2024 is affected.
Gills Onions has recalled fresh slivered red onions (product 5514182006) due to potential Salmonella Thompson contamination. The product was distributed across multiple U.S. states and Canadian provinces.
Gills Onions is recalling fresh diced yellow onions due to potential contamination with Salmonella Thompson. The recalled product was distributed to multiple US states and Canadian provinces.
Gills Onions is recalling 325 lb of fresh diced red onions due to potential Salmonella Thompson contamination. The product was distributed across multiple U.S. states and Canadian provinces.
Gills Onions is recalling Imperial Fresh diced yellow onions (2,035 lb) due to potential contamination with Salmonella Thompson. The affected product was distributed to multiple US states and Canadian provinces.
CareFusion is recalling the Alaris PCA Module 8120 infusion pump because its labeling lists compatible syringes that have not been validated for use with the device.
Gills Onions has recalled slivered red onions due to potential Salmonella Thompson contamination. The product was distributed across multiple U.S. states and Canadian provinces.
Gills Onions, LLC is recalling Cross Valley Farms 2/5 LB diced red onion product due to potential Salmonella Thompson contamination. The product was distributed to Canada and numerous U.S. states.
Gills Onions is recalling 8 oz cups of diced red onions due to potential Salmonella Thompson contamination. Products were distributed across the US and Canada.
Stryker Corporation is recalling 2,321 Spetzler-Malis bipolar surgical forceps due to incorrect expiration date labeling. The product label states a 54-month shelf life when the actual shelf life is only 36 months.
B. Braun recalls 30 ML 2PORT burette assemblies (lot 0061766049) for potential leakage due to manufacturing defect. Leakage risks delayed therapy, bloodstream infection, and medication exposure to patients and healthcare workers.
Stryker Corporation recalled 19 Portal Entry Kits distributed to surgical facilities in multiple U.S. states due to expired product. The kits aid surgeons in establishing arthroscopic portals.
Philips is recalling 7 Affiniti 70 diagnostic ultrasound systems with software version 10.0 due to a defect that may produce delayed imaging instead of real-time images.
Stryker is recalling 2,321 disposable Spetzler-Malis Bipolar forceps due to a labeling error showing an incorrect shelf life. The product label indicates 54 months, but the actual shelf life is 36 months.
Hinterland Dairy Inc is recalling Farmstead Cheese Mango Habanero (8oz packages, Lot 1670) distributed in Iowa due to potential E. coli contamination. Consumers should dispose of the product.
Philips Azurion IGTS Fixed Systems delivered to U.S. territories lack required safety components. The Source-to-Skin Distance Spacer and warning label are missing from affected units.
B. Braun Medical recalls THERASPHERE ADMIN SET due to manufacturing defects causing potential leakage. Leakage may delay therapy, increase bloodstream infection risk, and expose patients and healthcare workers to hazardous medication.
Philips is recalling Zenition 50 & 70 surgical C-arm systems distributed to Puerto Rico, Guam, and the Virgin Islands due to missing warning labels and safety spacers. These missing components may compromise radiation safety during surgical use.
Gills Onions, LLC is recalling Cross Valley Farms diced yellow onions due to potential contamination with Salmonella Thompson. The product was distributed across the United States and Canada.