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 Brilliance iCT CT scanners are recalled because fasteners securing the rotor may not be properly tightened. If multiple fasteners are loose, rotor parts could become unsecured or displaced.
F.H. Investments (Asteria Health) is recalling Estradiol 22 mg sterile pellets nationwide due to potential metal particulate matter contamination. Affected lot (253000126) expires 06/09/2026.
Asteria Health recalled Testosterone-Anastrozole injectable pellets due to potential metal particulate contamination. Affected lots 254000107 and 254000111 were distributed nationwide.
F.H. INVESTMENTS, Inc. (dba Asteria Health) is recalling testosterone pellets nationwide due to potential metal particulate matter contamination. Approximately 60,868 pellets across five lot numbers are affected.
Unichem Pharmaceuticals is recalling 60,000 Doxazosin Mesylate 4 mg tablets due to incorrect imprinting. Patients should check their medication bottles and contact their pharmacy if they have Lot #GDSH25006.
The Surepulse VS Cap Extra Large component of newborn heart rate monitors has been recalled because the product labeling contains an incorrect sizing guide.
Surepulse Medical recalls VS Cap Small components of newborn heart rate monitors due to incorrect sizing guidance in the labeling. The labeling error could affect proper device fit.
Medline Industries is recalling 2,448 suture removal kits due to potentially open packaging seals on BD ChloraPrep Triple Swabsticks applicators, which could compromise sterility.
Surepulse Medical is recalling the VS Cap Large, a component of the VS Newborn Heart Rate Monitor, due to incorrect sizing information in the labeling.
Domino Foods is recalling Sodexo Stars Saccharin packets because the product contains undeclared aspartame. The recall affects 2,023 cases distributed across multiple states.
Amerisource Health Services is recalling Oxycodone Hydrochloride Tablets, 5 mg, nationwide due to defective blister card seals. Weak or non-existent seals may allow tablets to fall out of their cavities.
Pro Numb Tattoo Numbing Spray (5% Lidocaine) is being recalled nationwide due to manufacturing process violations (cGMP deviations). Affected lots are J01-J14 and J55-J69 in 1 oz and 4 oz bottles.
Pro Numb Tattoo Numbing Spray (lot J15) is recalled nationwide due to manufacturing process deviations. The voluntary recall was initiated February 2, 2026.
Medline Industries is recalling 7,570 medical convenience kits containing BD ChloraPrep Triple Swabsticks due to potentially open seals on applicator packaging. The kits are distributed nationwide to hospital and clinical settings.
Surepulse Medical recalled the VS Cap Extra Small component of its newborn heart rate monitor due to an incorrect sizing guide in the product labeling.
Straumann USA is recalling 561 units of WB Impression Post Closed Tray due to incorrect impression caps in packaging. The caps are magenta instead of the intended brown color.
Surepulse Medical is recalling certain newborn heart rate monitor caps due to incorrect sizing information in the labeling. The issue affects specific lot numbers distributed in the US and internationally.
Everpress Juice is recalling JUICE from the Raw spicy lemonade products due to potential pathogenic bacteria from under-processing. The product was distributed in multiple states across the United States.
B.C. Williams Bakery Service is recalling Swiss Chocolate Cake Mix for containing undeclared milk allergen. Consumers with milk allergies should not consume this product.
Everpress Juice's 'From the Raw, upbeat' juice is being recalled because it may be under-processed and contain pathogenic bacteria. The product was distributed across 24 states.
Green Lumber Natural Fuel For Men capsules are recalled because FDA determined the product was marketed without required approval and contains the active ingredient tadalafil.
Rheumacare capsules (30-count bottles) are being recalled due to lead contamination discovered during manufacturing. The affected product was distributed to one customer in New York and should not be used.
FDA Class I recall of AXIOS Stents due to reported deployment and expansion failures. Affected patients may require device exchange or additional surgical intervention to remove the stent and close the puncture site.
Outside The Breadbox bread crumbs are being recalled due to undeclared egg and milk allergens. The recall affects 4,497 units distributed across eight states.
Boston Scientific is recalling 266 units of the HOT AXIOS Stent due to deployment and expansion issues that may require additional surgical intervention to remove the stent and close the puncture site.