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.
American Contract Systems Inc is recalling its ORIF HIP IM RODDING FEMUR-Procedure Kit (28 units) because ethylene oxide and ethylene chlorohydrin residuals in the cast padding exceeded safe limits for permanent implants.
Fresenius is recalling 17 Blood Pump Rotor spare parts nationwide due to loose or dislodged guide sheaves that develop after use. The affected rotor components are used in K@HOME dialysis machines.
American Contract Systems Inc is recalling HAND WRIST FOREARM-LF Procedure trays due to ethylene oxide sterilization residues exceeding safe limits for permanent exposure devices.
American Contract Systems Inc is recalling the HAND PACK-Procedure Kit (catalog WEHD16C) due to ethylene oxide and ethylene chlorohydrin residuals exceeding safety limits.
MICROspecialties is recalling the Synergetics I Pack Injection Kit because sterilization cannot be confirmed, potentially causing post-operative wound or injection site infections. Affected units are lot P62764979R distributed in Missouri.
American Contract Systems Inc is recalling a knee surgery procedure kit (24 units, Lot 939241) due to ethylene oxide sterilization residues in the cast padding exceeding safety exposure limits for permanent-implant devices.
Braun Thermoscan PRO 6000 ear thermometers may have been shipped with outdated Instructions for Use on an included CD. Approximately 265,647 units were distributed globally.
Zydus Pharmaceuticals recalls Micafungin for injection (Lot L300217) distributed nationwide due to potential cross contamination with other products. No illnesses have been reported.
Zydus Pharmaceuticals is recalling Verapamil Hydrochloride Injection vials nationwide due to potential cross contamination with other products.
Rising Pharma is recalling 868 tubes of Diflorasone Diacetate ointment because impurity levels failed to meet safety specifications during stability testing. No illnesses have been reported.
Barco display units may lose HDMI connectivity and become unusable when a specific Molex network module is installed in the ETH0 slot of affected models.
Suntegrity IMPECCABLE SKIN sunscreen foundation is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The recall involves 8,202 tubes distributed nationwide and internationally.
Silkprousa LLC is recalling the Pink Luminous Breast transilluminator because the device was marketed and distributed without FDA premarket approval. All 2,000 units distributed nationwide are subject to recall.
FDA is recalling 8,020 vials of Verapamil Hydrochloride Injection (Lot L300269) distributed nationwide due to potential cross contamination with other products.
American Contract Systems is recalling TOTAL KNEE procedure trays because sterilization gas residuals on the cast padding component exceed regulatory safety limits. No injuries have been reported.
Equibal Inc. is recalling Blemfree All Day Lotion due to manufacturing deviations from Current Good Manufacturing Practices. The product was distributed nationwide via internet sales.
American Contract Systems Inc recalls the TOTAL KNEE Procedure Kit due to Ethylene Oxide and Ethylene Chlorohydrin residuals exceeding regulatory limits. No illnesses reported.
Zydus Pharmaceuticals is recalling Micafungin for injection (100 mg/vial, Lot #L300220) due to potential cross-contamination with other products. Approximately 12,720 vials distributed nationwide in the USA and Puerto Rico are affected.
American Contract Systems Inc recalled a knee surgery procedure kit (Catalog RGTK10K) due to ethylene oxide and ethylene chlorohydrin residuals exceeding safety limits on the cast padding component.
Penn Herb Company is recalling Nature's Wonderland brand Thyroid Formula due to potential Salmonella contamination. Fifty-one bottles were distributed across nine states.
Megadyne is recalling the MEGA 2000 Patient Return Electrode due to identified potential risk of patient burns. Use is now restricted to patients aged 12 or older.
Walmart Great Value Organic Black Chia Seeds (32 oz) are being recalled due to potential Salmonella contamination. The product was distributed to multiple states.
To the Moon Capsules are being recalled nationwide because they contain undeclared sildenafil, a prescription pharmaceutical. The product was marketed without FDA approval.
Megadyne Medical recalls MEGA SOFT reusable patient return electrodes (Model 0830) due to identified burn risk. Use is restricted to patients aged 12 and older.
Integrity Products recalls RAM IT Horny Goat Weed dietary supplement capsules nationwide because they contain undeclared sildenafil, a prescription drug not listed on the label.