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 X-ray imaging systems delivered to Puerto Rico are missing warning labels and Source-to-Skin Distance Spacers. These missing safety components could affect user safety during imaging procedures.
Family Dollar is recalling 329,044 VERIQUICK pregnancy tests due to improper storage outside labeled temperature requirements. Affected units were sold at Family Dollar stores June-October 2023.
Philips recalled surgical C-arm systems in US territories without required warning labels and missing the Source-to-Skin Distance Spacer. Facilities should contact Philips for instructions on obtaining missing components.
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.
Amneal Pharmaceuticals is recalling Extended Phenytoin Sodium capsules nationwide (lot HM03221A) due to failed dissolution specifications, which means the tablets may not dissolve as intended.
Olympus Corporation is recalling 1,687 units of the EVIS EXERA III Gastrointestinal Videoscope nationwide due to sterilization failures that may occur when devices are reprocessed without adequate drying time in the endoscope channel.
Philips is recalling 13 DigitalDiagnost 4 Chest/Emergency radiographic imaging units due to a potential for ceiling-mounted units to fail and fall, posing injury risk.
Philips is recalling Zenition 50 & 70 surgical C-arm systems distributed to Puerto Rico, Guam, and the Virgin Islands due to missing warning labels and safety spacers. These missing components may compromise radiation safety during surgical use.
B. Braun Medical is recalling 12,800 units of TERUMO IV injection sets (Lot 0061753485) due to a manufacturing defect that may cause leakage, delaying therapy and increasing risk of bloodstream infection.
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.
Maquet Medical Systems USA is recalling 1,022 Cardiohelp-i blood oxygenation systems due to an insufficient weld on a critical component that may break under manual force.
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.
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.
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.
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.
B. Braun Medical is recalling 400 units of a 30ML burette assembly due to a manufacturing defect that may cause leakage, potentially delaying therapy and increasing bloodstream infection risk.
Philips is recalling 101 ProxiDiagnost N90 radiography and fluoroscopy systems due to potential failure of ceiling-mounted units, which could fall and cause injury.
Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps due to an expiration date labeling error. The label incorrectly shows a 54-month shelf life when the actual shelf life is 36 months.
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.
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.
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.
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.
Philips is recalling 33 DigitalDiagnost C90 radiographic imaging systems nationwide due to potential structural failure of ceiling-mounted units. Equipment may fall, creating injury risk.
Zydus Pharmaceuticals is recalling Oxybutynin extended-release tablets due to failed dissolution testing. The tablets may not dissolve properly, potentially affecting drug efficacy.
Gills Onions recalls diced yellow onions due to potential Salmonella Thompson contamination. The recall affects multiple states and Canadian provinces.