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.
Hikma Pharmaceuticals is recalling Abirtega (abiraterone acetate) 250 mg tablets because they failed weight uniformity specifications.
Medline Industries is recalling C-section drapes that are difficult to remove and leave adhesive residue on patient skin.
Boston Scientific is recalling 902 Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.
El Ruisenor De Mexico, Inc. is recalling soybeans in clear plastic packages because they contain an undeclared soy allergen. The product was distributed primarily to California and limited customers in other states.
Pritam International is voluntarily recalling 411,600 tubes of Brush Buddies Hot Wheels Anticavity Fluoride Toothpaste due to Current Good Manufacturing Practice (CGMP) deviations.
Medtronic is recalling NDI Passive Spheres and biopsy needle kits because reflective material variation may affect the navigation system's ability to detect and track the spheres.
El Ruisenor De Mexico, Inc. is recalling 11 pounds of wheat germ packaged in clear plastic units due to an undeclared wheat allergen. The product was distributed primarily to California customers.
El Ruisenor De Mexico, Inc. is recalling walnut halves due to an undeclared allergen ingredient. The product was distributed primarily in California and limited to other states.
El Ruisenor De Mexico, Inc. is recalling 4X6 and 4X8 Wheat Snacks because they contain an undeclared wheat allergen.
Boston Scientific is recalling 3,284 Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.
El Ruisenor De Mexico, Inc. is recalling shelled white pine nuts due to an undeclared allergen ingredient. The product was distributed primarily in California and limited to other states.
Pritam International is voluntarily recalling Brush Buddies toothpaste nationwide due to CGMP deviations. No illnesses or injuries are reported.
Pritam International is voluntarily recalling 198,288 tubes of Brush Buddies toothpaste nationwide due to Current Good Manufacturing Practice (CGMP) deviations.
El Ruisenor De Mexico, Inc. is recalling hulled sesame seeds due to an undeclared sesame allergen. The product was distributed primarily in California and limited areas in six other states.
Medline Industries is recalling 2,229 medical convenience kits because they are difficult to remove from patients and leave adhesive residue on the skin.
Boston Scientific is recalling 381 units of Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.
B Braun Medical Inc is recalling SAFSITE Injection Site valves due to a potential for leakage and backflow.
Boston Scientific is recalling 76 units of Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.
Philips North America is recalling 174 Smart-hopping 2.0 AP units due to unreliable wireless roaming behavior that can cause loss of connectivity to the central monitoring system.
El Ruisenor De Mexico, Inc. is recalling 123.5 pounds of Textured Soy Protein because the product contains soy, an allergen not declared on the label.
Boston Scientific is recalling 748 Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.
El Ruisenor De Mexico, Inc. is recalling black sesame seeds because the product contains an undeclared allergen ingredient (sesame).
El Ruisenor De Mexico, Inc. is recalling Butter Toffee Peanuts because the product contains undeclared peanuts and milk.
Boston Scientific is recalling 45 units of Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.
Boston Scientific is recalling 206 Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.