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.
Siemens Luminos dRF Max fluoroscopic imaging systems may occasionally display incorrect radiation dose measurements during certain operating conditions. The manufacturer states the error does not affect diagnosis or workflow.
TruVision Health LLC is recalling truControl W/Dynamine because the product contains DMHA and/or hordenine, which FDA has determined are not acceptable dietary ingredients.
TruVision Health's truCONTROL 60 Count dietary supplement is being recalled because it contains DMHA and/or hordenine, which the FDA has determined are not acceptable dietary ingredients.
Olympus is recalling 1,297 boxes of fine needle aspiration needles due to a manufacturing defect where the needle angle does not meet specifications, resulting in slight resistance during needle advancement and retraction.
Siemens Healthcare Diagnostics is reassigning Atellica CH Toxicology Calibrators due to a positive bias. The affected calibrators were distributed in the US and internationally across multiple countries.
ViziShot 2 Aspiration Needles are being recalled because the needle angle does not meet specifications and remains unbent, causing resistance during use. No illnesses or injuries have been reported.
Siemens Luminos Agile Max fluoroscopic imaging systems may occasionally display incorrect radiation dose information under certain unlikely circumstances. The manufacturer states there is no impact on clinical workflow or diagnosis. The error only occurs in systems with a second overhead X-ray tube.
LUMINOS Lotus Max fluoroscopic systems may sporadically display incorrect radiation dose measurements. The error only occurs with secondary X-ray tubes and does not affect diagnosis or workflow.
Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets 400mcg due to incorrect or missing package inserts in affected cartons distributed nationwide. No illnesses have been reported.
Culinaria Branded Roasted & Salted Colossal Cashew & Macadamia Mix (828 cans, Lot 3033A9) is being recalled due to a label mix-up. The product was distributed in Illinois, Indiana, and Missouri.
Teva Pharmaceuticals USA Inc is recalling Fentanyl Buccal Tablets 800mcg due to incorrect or missing package inserts. The recall affects 3,032 units distributed nationwide.
Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets 600mcg due to incorrect or missing package inserts in 1,908 units distributed nationwide across multiple lot numbers.
Amneal Pharmaceuticals recalls Methylprednisolone Acetate Injectable Suspension due to incorrect NDC number on product cartons. The typographical error appears on secondary packaging only; the medication vial itself is unaffected.
Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets 100mcg due to incorrect or missing package inserts in affected cartons. Patients should verify proper labeling or contact their pharmacy.
Highkey Soft Baked Mini Treats Birthday Cake was recalled because egg allergen was not listed on the label, causing an allergic reaction in a consumer. The product was distributed to seven U.S. states.
SW Texas Nut Blend (Item #5180819) is being recalled due to undeclared almonds and cashews. The product label lists only hazelnuts and walnuts as ingredients.
Draeger Medical recalls VentStar Anesthesia (N) 180 breathing circuits. Glued connections can loosen or detach during ventilation, potentially creating a critical disconnection risk.
General Mills is recalling Gold Medal Bleached All Purpose Flour nationwide due to potential Salmonella contamination. Approximately 271,454 bags are affected.
Draeger Medical is recalling the Anesthesia Set Coax 180 because glued breathing circuit connections can become loose during ventilation, causing partial or complete detachment.
Draeger Medical is recalling the Seattle PAP Plus due to glued breathing circuit connections that may loosen or completely detach during ventilation, potentially interrupting airflow.
ICU Medical is recalling the ASM Replacement Battery due to a manufacturing defect from the battery supplier. The defect may cause batteries to lose capacity and experience decreased runtime earlier than expected.
Draeger Medical recalls 2,380 Ventstar Coax breathing circuits due to glued connections that can become loose or detach during ventilation.
Draeger Medical recalls ID Coax 180 breathing circuit components due to glued connections that can become loose or detach during ventilation.
Highkey soft baked MINI TREATS BANANA NUT MUFFIN are being recalled due to undeclared egg on the label. A consumer experienced an allergic reaction to the product.
ICU Medical Inc is recalling 28,656 replacement batteries used in the Plum 360 Infusion System due to a manufacturing defect that causes premature capacity loss and decreased runtime. Affected units are distributed worldwide.