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.
CareFusion is recalling 133,727 units of the BD Alaris Syringe Module because the labeling lists compatible syringes that have not been validated for use with the infusion pump.
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 46 CombiDiagnost R90 radiography systems nationwide due to potential ceiling mount failure that could allow suspended units to fall, posing an injury risk.
Two different RSP humeral socket insert devices were swapped during packaging at Encore Medical. This could result in surgeons receiving an incorrect device for shoulder surgery, potentially delaying the procedure.
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.
Stryker Corporation is recalling 2,321 Disposable Spetzler-Malis Bipolar forceps due to incorrect shelf-life labeling. Products labeled with 54-month shelf life actually have a 36-month shelf life.
Philips DigitalDiagnost 4 Flex/Value radiographic systems may fail when ceiling-mounted and fall, posing injury risk. Recall affects 92 units distributed nationwide.
Stryker Corporation recalls Disposable Spetzler-Malis Bipolar forceps due to labeling error. Products are labeled for 54-month shelf life but have actual 36-month shelf life, risking use of expired sterile surgical equipment.
Hinterland Dairy Inc is recalling its Happy Jack Monterey Jack Cheese because it may contain E. coli. The affected cheese was distributed in Iowa.
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 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 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.
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.
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.
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.
AbbVie is recalling 864 cartons of Synthroid (Levothyroxine Sodium) 125mcg tablets due to incorrect barcode labeling. About 1 in 40 blister packs has a barcode showing 200mcg instead of 125mcg, risking dosage confusion.
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.
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.
Philips is recalling 83 EPIQ diagnostic ultrasound systems that may display delayed instead of real-time images due to a software issue, potentially affecting diagnostic imaging quality.
Taro Pharmaceuticals recalls 11,196 bottles of Hydrocortisone and Acetic Acid Otic Solution nationwide due to failed quality specifications including out-of-spec impurities and lower-than-established assay levels discovered during stability testing.
Pulmonx endobronchial valve devices may have been labeled with a shortened expiration date. The devices are usable until December 8, 2024.
Stryker recalls disposable Spetzler-Malis bipolar forceps due to incorrect shelf life labeling. The label states 54 months but the actual shelf life is 36 months.
Zydus Pharmaceuticals is recalling Oxybutynin Extended-Release Tablets (15 mg) after dissolution testing showed out-of-specification results at the 6-month mark. No illnesses have been reported.