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.
Encore Medical is recalling DJO EMPOWR Knee Punch Handles due to a manufacturing defect that may cause the handle tip to break during surgery, potentially disrupting the procedure.
Stryker is recalling 2,321 disposable Spetzler-Malis Bipolar forceps due to a labeling error showing an incorrect shelf life. The product label indicates 54 months, but the actual shelf life is 36 months.
Alcon Custom-Pak surgical procedure packs contain latex gloves but are labeled as 'latex-free,' posing an allergic reaction risk for healthcare workers and patients with latex allergies.
Gills Onions, LLC is recalling Cross Valley Farms diced yellow onions due to potential contamination with Salmonella Thompson. The product was distributed across the United States and Canada.
Stryker Corporation is recalling 2,321 Spetzler-Malis bipolar surgical forceps due to incorrect expiration date labeling. The product label states a 54-month shelf life when the actual shelf life is only 36 months.
Change Healthcare Radiology Solutions versions 14.0, 14.1, and 14.2 may fail to update records in external applications. Healthcare facilities using this software are affected across six countries.
DigitalDiagnost 4 High Performance radiographic systems may fail and fall from ceiling mounts. The FDA recalls 366 units distributed nationwide.
Stryker Corporation is recalling 2,321 units of disposable surgical forceps due to a labeling error. The label indicates a 54-month shelf life, but the products actually expire in 36 months.
Glenmark Pharmaceuticals is recalling Deferasirox 500mg tablets nationwide due to failed dissolution specifications affecting approximately 5,856 bottles across multiple lots.
Family Dollar is recalling DENTEMP ONE STEP temporary dental fillings sold between June 2023 and October 2023 in 22 states because they were stored outside labeled temperature requirements, which may affect product performance.
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.
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.
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.
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.
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.
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.
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.
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.
Philips is recalling Integris-Allura IGTS Fixed Systems delivered to Puerto Rico, Guam, and the Virgin Islands due to missing Source-to-Skin Distance Spacers and required warning labels.
Percussionaire Corporation recalled 212 Monitron II Waveform Analyzers due to screen freeze issues on visual displays. Affected units were serviced with PAL microprocessor chips and firmware updates.
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 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.
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.
B. Braun is recalling SA3000 intravenous adapters due to a manufacturing defect that may cause leakage. This could delay therapy, increase bloodstream infection risk, and expose patients and workers to hazardous medication.
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.