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 diced yellow onion products due to potential Salmonella Thompson contamination. The recalled product was distributed across multiple US states and Canadian provinces.
Pfizer Inc. is recalling 4.2% Sodium Bicarbonate Injection (24,900 vials) nationwide due to the presence of glass particulate matter. This Class I recall affects an injectable medication used in healthcare settings.
Olympus is recalling 1,154 EVIS EXERA II bronchovideoscope units due to risk of endobronchial combustion during high-frequency electrosurgical procedures when oxygen is supplied and electrode placement is inappropriate.
Cross Valley Farms Fresh Diced Yellow Onions are recalled due to potential Salmonella Thompson contamination. The product was distributed in the United States and Canada.
Gills Onions is recalling 24,430 lb of diced yellow onions due to potential Salmonella Thompson contamination. The affected product was distributed across the United States and Canada.
Gills Onions, LLC is recalling approximately 5,800 pounds of PEAK brand fresh diced yellow onions due to potential Salmonella Thompson contamination. The affected products were distributed across multiple U.S. states and Canadian provinces.
Tiffany Food Corp. is recalling Mini Fruit Jelly Cups due to choking hazard. The product was distributed in New York, New Jersey, and Pennsylvania.
WANABANA apple cinnamon fruit puree pouches are recalled due to high levels of lead detected by the North Carolina Department of Health and Human Services. Approximately 2.99 million units are affected across multiple regions.
Gills Onions, LLC recalls Cross Valley Farms fresh slivered yellow onions for potential Salmonella Thompson contamination. The 1,800 lb recall affects 37 U.S. states and 5 Canadian provinces.
Cordis US Corp is recalling cardiac catheter sets (Lot 18223410) distributed in Oklahoma. The devices were non-sterile but labeled as sterile, creating infection risk to patients.
Gills Onions, LLC is recalling Imperial Fresh diced red onions due to potential Salmonella Thompson contamination. The affected product was distributed across the United States and Canada.
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.
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.
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.
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 is recalling Imperial Fresh diced red onions due to potential Salmonella Thompson contamination. The product was distributed across multiple US 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.
Gills Onions, LLC is recalling Imperial Fresh slivered red onions due to potential contamination with Salmonella Thompson. The recalled products were distributed across the United States and Canada.
Gills Onions, LLC is recalling Cross Valley Farms diced yellow onions due to potential Salmonella Thompson contamination. The recall affects products distributed across the United States and Canada.
Gills Onions is recalling Imperial Fresh diced yellow onions due to potential Salmonella Thompson contamination. Consumers should not consume affected products.
Gills Onions is recalling Ready Set Serve diced yellow onions due to potential Salmonella Thompson contamination. The product was distributed across Canada and the United States.
Gills Onions is recalling Imperial Fresh diced yellow onions due to potential Salmonella Thompson contamination. The affected product was distributed to multiple states and Canadian provinces.
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 Imperial Fresh diced red onions due to potential Salmonella Thompson contamination. The product was distributed to foodservice and retail distributors in the United States and Canada.
Imperial Fresh diced red onions distributed across the US and Canada are being recalled due to potential Salmonella Thompson contamination. The affected product was distributed to multiple states and provinces.