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.
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.
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 Cross Valley Farms diced yellow onions due to potential Salmonella Thompson contamination. The recall affects products distributed across the United States and Canada.
Imperial Fresh diced yellow onions from Gills Onions, LLC are being recalled due to potential Salmonella Thompson contamination. The recall affects 88,660 lb distributed across the US and Canada.
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.
Greenhead Lobster Products is recalling frozen and fresh ready-to-eat lobster meat that may be contaminated with Listeria monocytogenes. The recall affects multiple states.
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 diced yellow onions due to potential Salmonella Thompson contamination. The 1,940-pound recall affects products distributed in 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 31 U.S. states and five Canadian provinces.
Philips EasyDiagnost Eleva DRF digital radiographic systems mounted on ceilings may fail and fall. 40 units nationwide are being recalled due to potential ceiling mount failure.
Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar Forceps because the product label incorrectly shows a 54-month shelf life when the actual shelf life is 36 months.
B. Braun Medical is recalling 175,000 units of bulk largebore male LL fittings due to a manufacturing defect that may cause leakage, potentially increasing bloodstream infection risk.
St. Jude Medical is recalling CardioMEMS Patient Electronic System (Model CM1100) because the power connector plug may become damaged and frayed if bent beyond 90 degrees. This could cause device malfunction or electrical hazard.
B. Braun is recalling FT1000S Fluid Transfer Sets due to a manufacturing defect that may cause leakage. This could delay therapy, increase infection risk, and expose healthcare workers to hazardous medication.
Stryker Corporation recalls 2,321 units of Disposable Spetzler-Malis Bipolar forceps due to incorrect expiration dates on product labels. The actual shelf life is 36 months, but labels indicate 54 months.
The Cookie Factory LLC is recalling Stewarts Chocolate Chip Cookies (6 oz packages) because they contain undeclared macadamia nuts, posing an allergen risk to consumers with macadamia nut allergies.
Philips has recalled certain surgical C-arm imaging systems delivered to Puerto Rico because they lack required warning labels and are missing a critical Source-to-Skin Distance Spacer component.
Family Dollar Stores is recalling 329,044 CLEARBLUE pregnancy test kits that were stored outside labeled temperature requirements from June to October 2023 at stores in 22 states.
B. Braun Medical is recalling Allergan Universal Fill Kits for tissue expanders due to a manufacturing defect that may cause device leakage. Leakage can delay treatment, increase infection risk, and potentially create life-threatening situations.
Carestream Health is recalling 2,402 DRX-Revolution Mobile X-Ray Systems due to potential electrical failure in the generator causing thermal overload. The system becomes inoperable and may produce loud noise, burnt smell, and smoke.
Nutricia is recalling KetcoCal 4:1 LQ Unflavored sample kits due to incorrect product in packaging. A total of 283 kits distributed to the US and Canada expire December 10, 2023.
Zydus Pharmaceuticals is recalling Oxybutynin extended-release tablets due to failed dissolution testing. The tablets may not dissolve properly, potentially affecting drug efficacy.
Philips is recalling two units of its DigitalDiagnost C90 Release 3.1 radiographic imaging system due to potential failure of ceiling-mounted units, which could fall.
B. Braun Medical is recalling AMO ophthalmologic administration sets due to a manufacturing defect causing potential leakage. This may delay therapy and expose patients and healthcare workers to hazardous medication.
Philips DigitalDiagnost C90 Release 3 ceiling-mounted imaging system faces potential suspension failure risk. The FDA issued a Class II recall for nationwide-distributed Model 712025 due to risk of equipment falling.