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 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.
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.
Tiffany Food Corp. is recalling Mini Fruit Jelly Cups (Mango flavor) distributed in NY, NJ, and PA due to choking hazard.
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.
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.
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.
Cookies-n-Milk Incorporated is recalling Edible Cookie Dough Chocolate Chip due to undeclared peanut butter. The product contains peanut butter dough mislabeled as chocolate chip, posing a risk to consumers with peanut allergies.
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, LLC has recalled Cross Valley Farms diced red onions due to potential Salmonella Thompson contamination. The recall affects products distributed across the United States and Canada.
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 recalls diced yellow onions due to potential Salmonella Thompson contamination. The recall affects multiple states and Canadian provinces.
Gills Onions, LLC is recalling Cross Valley Farms fresh slivered yellow onions due to potential Salmonella Thompson contamination. Distribution affected the United States and Canada.
Gills Onions is recalling Imperial Fresh slivered yellow onions due to potential Salmonella Thompson contamination. The recall affects onions distributed across the United States and Canada.
Gills Onions is recalling Imperial Fresh slivered 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 4/5 LB slivered yellow onions due to potential contamination with Salmonella Thompson.
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.
Weis brand cinnamon apple sauce pouches are recalled due to high levels of lead contamination detected by the North Carolina Department of Health and Human Services. Consumers should stop consuming the product and contact their healthcare provider if concerned.
CareFusion 303, Inc. is recalling the Alaris PCA Module 8120 infusion pump because its labeling lists compatible syringes that have not been validated. This Class I recall affects 867,362 units worldwide.
Gills Onions is recalling Cross Valley Farms diced yellow onions due to potential Salmonella Thompson contamination. The product was distributed to 36 U.S. states and five Canadian provinces.
Gills Onions is recalling PEAK brand fresh diced red onions due to potential Salmonella Thompson contamination. The recall affects products distributed across 35 US states and five Canadian provinces.
Gills Onions 8 oz cups of diced yellow onions are being recalled due to potential contamination with Salmonella Thompson. Consumers should not consume affected products and should discard them or return them to the place of purchase.
Baxter's Novum IQ Syringe infusion system may display a false 'Infusion Complete' alarm after multiple occlusion events, leaving uninfused fluid in the syringe and risking incomplete medication delivery.
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.
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.
Gills Onions is recalling diced yellow onions due to potential Salmonella Thompson contamination. Consumers should not consume the affected product.