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.
Tailor Made Compounding is recalling 652 vials of Methylcobalamin 10mg/mL injectable due to lack of assurance of sterility. No illnesses or injuries have been reported.
Tailor Made Compounding is recalling 294 vials of Gonadorelin 100mcg/mL distributed nationwide because the manufacturer cannot assure the product meets sterility standards.
Tailor Made Compounding recalls 349 vials of Estradiol Cypionate 10mg/mL due to lack of assurance of sterility. The product was distributed nationwide in the USA and Puerto Rico.
Aesculap Implant Systems LLC is recalling TC Cooely Micro Needleholder instruments because units labeled as 200mm are actually 150mm. This labeling error could impact surgical procedures.
Tailor Made Compounding is recalling 93 vials of Testosterone Enanthate due to lack of assurance of sterility. The affected batches were distributed nationwide and in Puerto Rico.
Hamilton Medical's HAMILTON-H900 humidifier (models 950001, 950004) is recalled due to delayed low-water level alarms that may prevent medical staff from detecting an empty chamber during mechanical ventilation use.
TMC Acquisition LLC is recalling Testosterone Cypionate injectable vials (100mg/ml) due to lack of assurance of sterility. The recall affects 273 vials distributed nationwide in the USA and Puerto Rico.
Fresenius Medical Care is recalling NATURALYTE Liquid Acid dialysate because bottle caps are not qualified for use. The recall affects 163 cases of lot 22CTAC102 distributed nationwide.
A compounded sermorelin/glycine injectable has been recalled because the manufacturer cannot assure the product is sterile. The recall affects approximately 2,870 vials distributed nationwide.
FDA recalls certain Endo Model orthopedic implants because the blind screws may not loosen during surgery, potentially requiring surgeons to change their approach and prolonging the procedure.
Medtronic MiniMed is recalling 83,398 MiniMed 780G insulin pumps distributed throughout the United States due to battery cap deterioration that may cause power loss and device malfunction.
Ortho-Clinical Diagnostics is recalling Anti-SARS-CoV-2 IgG Quantitative Reagent Pack because the Instructions For Use incorrectly state on-analyzer stability of 8 weeks when the actual supported time is 6 weeks.
Tailor Made Compounding is recalling 243 vials of Nandrolone Decanoate injectable medication due to lack of sterility assurance. The affected product was distributed nationwide in the USA and Puerto Rico.
Tailor Made Compounding is recalling 1,856 vials of NAD+ 200mg/mL because the company cannot assure the product meets sterility requirements. The affected vials were distributed nationwide to the United States and Puerto Rico.
Medtronic MiniMed is recalling the MiniMed 630G insulin pump due to battery cap deterioration that may cause loss of power and function. Approximately 126,558 units distributed in the U.S. and Canada are affected.
Medtronic is recalling MiniMed 770G insulin pumps because battery cap deterioration may cause power loss and insulin delivery failure. Approximately 123,585 units are affected.
AquaBplus 2000 water purification systems for dialysis have an installation guideline error that may reduce heat disinfection effectiveness. Patients using affected units may be at risk.
Medtronic MiniMed 620G insulin pumps may experience battery cap deterioration, resulting in incomplete battery circuit and loss of power. Approximately 2,287 affected pumps have been distributed across the U.S.
Ultradent Peak Universal Bond self-etch dental primers may be missing resin, potentially compromising bond strength. Affected products were distributed nationwide and internationally.
Tailor Made Compounding is recalling 25 vials of a compounded injectable product due to lack of assurance of sterility. The affected batches were distributed nationwide.
Tailor Made Compounding recalls 101 vials of Glycyrrhizic Acid (8mg/mL) nationwide due to lack of assurance of sterility in this injectable preparation. Patients should contact their healthcare provider.
Isopure is recalling approximately 119 units of the Sodium Bicarbonate Mixing and Distribution System due to an electrical short causing a thermal event and device damage. No injuries reported.
Methylene Blue Hypotonic Solution vials are being recalled nationwide and in Puerto Rico due to lack of assurance of sterility. Affected vials should not be used.
Walker & Sons Inc is recalling Slap Ya Mama Cajun Fish Fry due to undeclared wheat allergen. Consumers with wheat allergies should not consume the product.
Philips DigitalDiagnost 4 radiography systems may deliver incorrect radiation doses due to a Wallstand VS2 firmware issue causing incorrect image orientation and misaligned anatomical markers.