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.
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.
Medtronic is recalling StealthStation S8 and FlexENT systems with software versions 2.0 and 2.0.1 due to a software anomaly that could cause surgical planning data to shift to an unintended location.
Gills Onions is recalling 800 pounds of PEAK brand diced red onions due to potential contamination with Salmonella Thompson. The product was distributed across the United States and Canada.
Tiffany Food Corp. is recalling Mini Fruit Jelly Cups (Mango flavor) distributed in NY, NJ, and PA due to choking hazard.
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.
Gills Onions is recalling 10 oz cups of diced mirepoix due to potential Salmonella Thompson contamination. Affected products were distributed across Canada and the United States.
Schnucks apple sauce fruit pouches with cinnamon are being recalled because North Carolina health officials found high levels of lead in the product. Consumers should not consume the affected pouches.
Gills Onions is recalling Ready Set Serve diced yellow onions due to potential Salmonella Thompson contamination. The recalled products were distributed across 33 US states and 5 Canadian provinces.
Gills Onions is recalling Imperial Fresh 4/5 LB slivered yellow onions due to potential contamination with Salmonella Thompson.
Gills Onions is recalling diced yellow onions sold under the Ready Set Serve brand due to potential Salmonella Thompson contamination. The affected product was distributed in the United States and Canada.
Diced yellow onions branded as PEAK are being recalled by Gills Onions due to potential Salmonella Thompson contamination. The product was distributed across the United States and Canada.
HEB Kale Greens in Texas are being recalled due to possible Listeria monocytogenes contamination. Consumers should discard the affected product or return it to the store.
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, 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 is recalling Imperial Fresh diced yellow onions due to potential Salmonella Thompson contamination. Consumers should not consume affected products.
Gills Onions, LLC is recalling fresh 1/2-inch diced yellow onions due to potential Salmonella Thompson contamination. The product should be discarded or returned to the point of purchase.
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, 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 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.
Gills Onions, LLC is recalling Imperial Fresh diced yellow onions due to potential Salmonella Thompson contamination. The product was distributed across multiple U.S. states and Canadian provinces.
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 Imperial Fresh slivered yellow onions due to potential Salmonella Thompson contamination. The recall affects products distributed across the US and Canada.
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 5,960 lb of Ready Set Serve sliced onions due to potential Salmonella Thompson contamination. The affected product was distributed across Canada and 36 U.S. states.
Gills Onions is recalling Imperial Fresh slivered red onions (760 lb) due to potential Salmonella Thompson contamination. Affected lot codes were distributed to 38 US states and five Canadian provinces.