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.
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.
DigitalDiagnost 4 High Performance radiographic systems may fail and fall from ceiling mounts. The FDA recalls 366 units distributed nationwide.
Stryker Corporation recalled disposable surgical forceps with mislabeled expiration dates. The product label incorrectly indicates a 54-month shelf life when the actual shelf life is 36 months.
Stryker Corporation is recalling 2,321 units of disposable bipolar surgical forceps with incorrect expiration dates on their labels. The devices are labeled with a 54-month shelf life when the actual shelf life is 36 months.
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.
Philips Azurion IGTS Fixed Systems delivered to U.S. territories lack required safety components. The Source-to-Skin Distance Spacer and warning label are missing from affected units.
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.
Philips is recalling 7 Affiniti 70 diagnostic ultrasound systems with software version 10.0 due to a defect that may produce delayed imaging instead of real-time images.
Ortho-Clinical Diagnostics is recalling VITROS Lipase Slides due to measurement abnormalities that could result in falsely low or elevated test results. This could delay diagnosis of acute pancreatitis or cause diagnostic confusion.
Hinterland Dairy Inc is recalling Farmstead Cheese Mango Habanero (8oz packages, Lot 1670) distributed in Iowa due to potential E. coli contamination. Consumers should dispose of the product.
B. Braun Medical recalls THERASPHERE ADMIN SET due to manufacturing defects causing potential leakage. Leakage may delay therapy, increase bloodstream infection risk, and expose patients and healthcare workers to hazardous medication.
Breg Inc is recalling 11,193 folding walkers with misaligned wheels that do not meet product specifications. The defect could affect stability and increase fall risk.
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.
Glenmark Pharmaceuticals is recalling Deferasirox 500mg tablets nationwide due to failed dissolution specifications affecting approximately 5,856 bottles across multiple lots.
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.
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.
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.
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.
Encore Medical recalls RSP Humeral Socket Insert implant components due to a packaging error where two different devices were swapped. This could prevent surgeons from having the correct implant available during shoulder surgery.
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.
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.
Abbott Laboratories has recalled Similac Probiotic Tri-Blend infant supplement packets due to regulatory violations: the product was marketed without FDA approval as a new drug and contains an unsafe food additive.
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.
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.