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.
Braun Thermoscan PRO 6000 ear thermometers may have been shipped with outdated Instructions for Use on an included CD.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.
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.
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.
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.
American Contract Systems Inc recalls the TOTAL KNEE Procedure Kit due to Ethylene Oxide and Ethylene Chlorohydrin residuals exceeding regulatory limits. No illnesses 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.
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.
Walmart Great Value Organic Black Chia Seeds (32 oz) are being recalled due to potential Salmonella contamination. The product was distributed to multiple 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.
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 MEGA SOFT Dual Reusable Patient Return Electrodes are recalled due to an identified risk of patient burns. Use should be restricted to patients aged 12 or older.
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.
Sun Pharmaceutical is recalling Decitabine for Injection (lot HAD2964A, 2,088 vials) for a Current Good Manufacturing Practice deviation. The Total Aerobic Microbial Count test on unfiltered bulk was out of specification; the product was distributed nationwide.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry FS Diluent Pack 3, Lot 01-1645, because it may produce negatively biased results when used with CRP slides, potentially affecting patient diagnosis and care.
Breadbox Co. is recalling Breadman Brioche products (Toast, Buns, Sliders, Hot Dog) distributed in Southern California due to undeclared Yellow No. 5, which may affect consumers sensitive to this color additive.
First Source Inc is recalling the First Source Vision M portable X-ray cart because the bolt securing the positioning arm to the gas spring may come loose and fall onto a patient.
Medisca Inc. is recalling 113 bottles of Budesonide, USP (Micronized) 500 mg due to glass particulate matter contamination caused by manufacturing deviations. The product was distributed nationwide in the USA and Canada.
Angiodynamics is recalling IsoLoc Prostate Immobilization Balloons (ISO-100, Lot 5402) for mislabeling. Devices have 100cc fill volume but are labeled as ISO-60 (60cc).
Siemens ARTIS icono angiography systems with certain detectors may deliver higher-than-intended radiation doses in rare cases. The issue occurs when incorrect copper prefiltration is applied during initial x-ray exposure after patient registration.
SeaSpine Orthopedics is recalling Fathom Pedicle-Based Retractor C/C Blades due to manufacturing defects that could cause bone fracture. The recall affects 31 units distributed across nine US states.