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.
Philips is recalling the Spectral CT on Rails (Model 728334, Software Version 5.1.0) due to a software crash that occurs when CCT Fluoroscopy mode and foot pedal are activated simultaneously. The crash requires system restart.
Omega & Delta Co. is recalling DOP Instant Hand Sanitizer because certain lot numbers did not meet potency acceptance criteria. Affected products were distributed in Puerto Rico only.
ORALE! CAMARON NATURAL shrimp in 2 oz. packages (Lot F-219) is recalled due to undeclared Red #40 food coloring. Approximately 7,584 units were distributed domestically.
ORALE! CAMARON MOLIDO ground shrimp (Lot F-219) is recalled due to undeclared Red #40 food coloring. No illnesses have been reported.
EL CHILAR natural shrimp (2 oz packages, Lot F-219) recalled due to undeclared Red #40 food coloring. The product was voluntarily withdrawn from domestic distribution.
Four Siemens Mobilett Mira wireless mobile x-ray systems are recalled due to incorrect buzzer component mounting that prevents acoustic signals during x-ray activation. The systems remain fully functional with visual LED indicators available for operator monitoring.
Tay's Sales and Distribution is recalling Full Spectrum Cold Pressed Hemp Oil Gummies due to undeclared sub-ingredients in the sunflower butter component. The products were distributed in Iowa and Illinois.
Blum's Shrimp Shred dried shrimp is recalled due to undeclared Red #40 food coloring. Affected lot 230828 was distributed domestically in the United States.
Gills Onions is recalling Cross Valley Farms diced yellow onions due to potential Salmonella Thompson contamination. The product was distributed across the United States and Canada.
Gills Onions is recalling fresh slivered yellow onions due to potential Salmonella Thompson contamination. The affected product was distributed to Canada and the United States.
Gills Onions is recalling fresh diced yellow onions due to potential Salmonella Thompson contamination. Approximately 16,400 pounds of product was distributed across multiple U.S. states and Canadian provinces.
Little Bear Fresh Kale from Safeway Fresh Foods LLC is being recalled due to possible Listeria monocytogenes contamination. The recall affects 191 cases distributed in Texas.
Gills Onions is recalling Ready Set Serve slivered yellow onions because of potential Salmonella Thompson contamination. The FDA has classified this as a Class I recall.
Gills Onions is recalling 4,160 pounds of fresh diced yellow onions due to potential contamination with Salmonella Thompson. The products were distributed across the United States and Canada.
Gills Onions is recalling PEAK brand diced yellow onions due to potential Salmonella contamination. Product was distributed across the United States and Canada.
Gills Onions is recalling Imperial Fresh sliced red onions due to potential Salmonella Thompson contamination. The product was distributed across 31 U.S. states and Canadian provinces.
Gills Onions, LLC is recalling specific lots of PEAK 4/5 lb fresh diced yellow onions due to potential Salmonella Thompson contamination. The affected product was distributed across Canada and multiple U.S. states.
Olympus Corporation recalls 13,950 EVIS EXERA II bronchovideoscopes due to risk of endobronchial combustion when high-frequency cauterization is performed with oxygen supplied while the electrode is positioned too close to the endoscope.
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 Cross Valley Farms slivered yellow onions due to potential Salmonella Thompson contamination. The recall affects 6,400 pounds distributed across the United States and Canada.
Tiffany Food Corp. is recalling Mini Fruit Jelly Cups with lychee flavor because they pose a choking hazard. The recall covers 120 cases distributed in New York, New Jersey, and Pennsylvania.
Olympus is recalling 719 EVIS EXERA b Bronchovideoscope Model BF-XT190 devices due to risk of endobronchial combustion during high-frequency cauterization when oxygen is supplied or the electrode is too close to the device tip.
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.
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.