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 recalls FLIXENE vascular grafts due to reported separation between the slider rod and swivel core. Affected grafts may fail to function properly if deployed.
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 is recalling the FLIXENE vascular graft due to reported separation of the Slider GDS Swivel Rod from its core. Component separation could affect graft function.
Atrium Medical is recalling ADVANTA VXT vascular grafts due to complaints of separation between the slider rod and swivel core, which could affect proper device function.
Atrium Medical is recalling 53,308 ADVANTA VXT vascular grafts due to reports of Slider GDS Swivel Rod separation from the Swivel Core. Component separation could compromise device function.
CORENTEC is recalling LOSPA Tibial Insert knee implant components due to an unsupported 10-year expiration date. Patients with these devices should consult their physician.
Medline Industries is recalling over 5 million Luer Slip disposable syringes because testing documentation does not confirm they deliver accurate volumes across their claimed capacity range. This poses a risk to patient health.
ADVANTA VXT vascular grafts may experience separation of the slider component from its core. This Class II recall affects 53,308 units distributed worldwide.
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.
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.
Philips is recalling the HA FlexTrak patient transport trolley due to potential oil leaks from the hydraulic system that create slipping and falling hazards. Approximately 100 units have been distributed worldwide.
Rise Baking Company is recalling approximately 29,019 cases of Panera Oatmeal Raisin with Berries Cookie dough pucks due to potential Salmonella contamination. The affected products were distributed across 20 states.
Atrium Medical is recalling the ADVANTA VXT vascular graft due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. This component separation could affect device function.
ADVANTA VXT vascular grafts may have separation of the Slider GDS Swivel Rod from the Swivel Core. Atrium is recalling affected units.
Glenmark Pharmaceuticals is recalling Rizatriptan Benzoate 10mg tablets nationwide due to N-nitroso impurity levels exceeding FDA acceptable limits, affecting 13,296 cartons.
Stryker Neurovascular is recalling certain lots of Synchro Neuro Guidewires due to PTFE coating damage that can occur when using a backloading technique with the optional introducer. Clinicians should avoid the backloading technique with affected product.
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.
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reports of the swivel rod separating from the swivel core. Patients and healthcare providers should contact the manufacturer for guidance.
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to separation of the Slider GDS Swivel Rod from the Swivel Core. Over 53,000 units affected worldwide.
Verathon recalls 1,706 GlideScope Core 15-inch FHD monitors due to a software defect in versions v1.7 and earlier. The defect can cause loss or degradation of image when the monitor is used with other connectable devices.
Atrium Medical Corporation is recalling FLIXENE vascular grafts due to reports of the slider swivel rod separating from the swivel core. The separation could affect device function during vascular procedures.
Atrium Medical recalls Advanta VXT vascular grafts due to swivel rod separation from the core component. Approximately 53,308 units are affected worldwide.
FDA recalls FLIXENE vascular grafts after complaints that the swivel rod separates from the swivel core. The defect affects over 53,000 units distributed worldwide.
Atrium Medical recalls ADVANTA VXT vascular grafts due to reports of swivel rod separation from the swivel core. Affected units distributed worldwide; healthcare providers should evaluate appropriate management.
Philips HA FlexTrak II patient transport trolleys may leak hydraulic oil onto the floor when pressed, creating a slip and fall hazard. About 590 units are affected worldwide.