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.
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reports of separation between the Slider GDS Swivel Rod and Swivel Core, which could affect device function.
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. Approximately 53,308 units worldwide are affected.
Ion Beam Applications' IBA Proton Therapy System PROTEUS 235 may continue delivering radiation when critical accelerator control parameters are outside defined tolerances. Affected users should contact the manufacturer regarding firmware updates.
ADVANTA VXT vascular grafts are being recalled because the Slider GDS Swivel Rod may separate from the Swivel Core. This affects about 53,308 units distributed worldwide including the US.
Atrium Medical is recalling ADVANTA VXT vascular grafts due to reports of the slider GDS swivel rod separating from the swivel core. Approximately 53,308 units are affected worldwide.
ADVANTA VXT vascular grafts may have separation of the Slider GDS Swivel Rod from the Swivel Core. Atrium is recalling affected units.
Atrium Medical's ADVANTA VXT vascular grafts are being recalled worldwide due to reports of the Slider GDS Swivel Rod separating from the Swivel Core. The separation creates a gap that could compromise device function.
Atrium Medical recalled 53,308 ADVANTA VXT vascular grafts worldwide due to reported separation of the swivel rod from the swivel core. The affected units were distributed throughout the United States and to 60 additional countries.
Stryker Neurovascular recalls certain lots of Synchro SELECT Guidewires due to PTFE coating damage that may occur when using a backloading technique. The damage is caused by sharper-than-intended edges on older introducer versions.
Atrium Medical is recalling ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from its Swivel Core. The recall affects 53,308 units distributed worldwide.
Atrium Medical Corporation is recalling its ADVANTA VXT vascular grafts due to complaints of swivel rod separation from the swivel core, which could affect device function and patient safety.
Becton Dickinson is recalling 2,061 kits of BD SARS-CoV-2 Reagents for BD MAX Systems because they may produce false negative results due to decreased enzyme activity. The kits were distributed nationwide and internationally.
Nihon Kohden's BSM-3000 Series Bedside Monitors may produce false SpO2 probe failure alarms due to a software issue. Healthcare facilities should contact the manufacturer for guidance.
ADVANTA VXT vascular grafts may experience separation of the slider component from its core. This Class II recall affects 53,308 units distributed worldwide.
Atrium Medical is recalling 53,308 ADVANTA VXT vascular grafts worldwide due to reported separation of the slider rod from the swivel core, with a gap observed between the components.
Atrium Medical is recalling ADVANTA VXT vascular grafts due to reports of the slider rod separating from the swivel core, which could impair proper device function.
Atrium Medical Corporation is recalling FLIXENE vascular grafts due to reported separation of the swivel rod from the core component. This defect could compromise device function.
Glenmark Pharmaceuticals recalls certain Rizatriptan Benzoate tablets due to N-Nitroso Desmethyl Rizatriptan impurity levels exceeding FDA acceptable limits. The affected lots were distributed nationwide.
Schreiber Foods Inc is recalling 835,721 units of Essential Everyday Blueberry Cream Cheese Spread (8 oz) due to potential Salmonella contamination. No illnesses have been reported.
Atrium Medical Corporation is recalling the Advanta VXT vascular graft due to reports of the swivel rod separating from the swivel core. The recall affects approximately 53,308 units distributed in the United States and worldwide.
Atrium Medical Corporation recalled 53,308 ADVANTA VXT vascular grafts worldwide due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. Patients should consult their healthcare provider regarding appropriate follow-up care.
Rise Baking Company is recalling Cowboy Cookie dough pucks distributed across 20 states due to potential Salmonella contamination. Affected cases are identified by code 4117N1.
Atrium Medical is recalling ADVANTA VXT vascular grafts due to reported separation of the slider mechanism from the core component, which could compromise device integrity.
The Arial mobile application experiences frequent restarts on iOS 17.4 and 17.5, causing alert overload, communication failures, and offline status in healthcare facilities.
Olympus OES 4000 Hysteroscope Model A4674A is being recalled because a required leakage test was not performed after device repairs. Liquid could enter the eyepiece, causing a foggy image during use.