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.
The FDA is recalling Draeger Medical's Ventstar Coax 230 breathing circuit components due to glued connections that can become loose and detach during ventilation, potentially compromising patient breathing support.
Draeger Medical is recalling VentStar breathing bag sets nationwide due to loose glued connections in the breathing circuit. Connections can detach before or during ventilation.
Draeger Medical is recalling the Seattle PAP Plus due to glued breathing circuit connections that may loosen or completely detach during ventilation, potentially interrupting airflow.
Draeger Medical is recalling its Anesthesia Circuit Kit Coax HEPA (720 units) because glued connections can become loose during ventilation, potentially causing partial or complete detachment that could interrupt oxygen delivery during surgery.
Abiomed is recalling 610 units of the Impella 5.5 with SmartAssist catheter due to a heightened complaint rate for purge leaks. This intravascular pump provides circulatory support during critical care.
Willamette Hazelnut, Inc. is recalling Oregon Nut Blend because it contains undeclared almonds and cashews. This poses a risk to consumers allergic to these nuts.
Draeger Medical is recalling VentStar Coax (P) 150 breathing circuit components due to potentially loose glued connections that could detach during ventilation, affecting 280 units distributed nationwide.
ICU Medical Inc is recalling 28,656 replacement batteries used in the Plum 360 Infusion System due to a manufacturing defect that causes premature capacity loss and decreased runtime. Affected units are distributed worldwide.
ICU Medical Inc is recalling replacement batteries used in Plum A+ and A+3 infusion pump systems. A manufacturing defect may cause batteries to lose capacity earlier than expected.
Kenover Marketing Corp. is recalling Mighty Sesame Organic Tahini due to potential Salmonella contamination. The affected product was distributed to multiple states.
General Mills is recalling Gold Medal Unbleached All Purpose Flour for potential Salmonella contamination. The recall affects 142,408 bags distributed nationwide with best-by dates of March 27–28, 2024.
Draeger Medical is recalling the Anesthesia Set Coax 180 because glued breathing circuit connections can become loose during ventilation, causing partial or complete detachment.
Lipari Foods is recalling 147 cases of ground cumin contaminated with Salmonella. The product was distributed to retail stores across 16 states.
Draeger Medical is recalling 1,725 VentStar Basic ventilators because glued breathing circuit connections can become loose and detach before or during ventilation. This may disrupt patient breathing support.
ICU Medical is recalling the ASM Replacement Battery due to a manufacturing defect from the battery supplier. The defect may cause batteries to lose capacity and experience decreased runtime earlier than expected.
Draeger Medical is recalling Anesthesia Circuit Kit Coax 3 units because glued connections can become loose or detach before or during ventilation. The recall covers 329,294 units distributed nationwide.
Draeger Medical is recalling the VentStar Bag Set because glued connections on the breathing circuit can become loose or detach during ventilation, potentially compromising respiratory support.
Draeger Medical is recalling 200 units of the VentStar Basic ventilator due to glued breathing circuit connections that can loosen or detach before or during ventilation.
Glued connections on the VentStar Watertrap breathing circuit can become loose or detach during ventilation, potentially interrupting airflow. Draeger Medical is recalling all affected units nationwide.
Draeger Medical is recalling Anesthesia Circuit Kit Coax 1 (MP02730) because glued breathing circuit connections can become loose or detach during ventilation, affecting the breathing circuit's function.
Draeger Medical is recalling 18,160 Ventstar Coax 180 ventilators because glued breathing circuit connections can become loose and detach during use, potentially disrupting oxygen delivery.
Draeger Medical is recalling Set2Go Ventilation 12 devices due to defective glued connections in the breathing circuit that can loosen or detach during ventilation.
Draeger Medical is recalling ID Circuit Basic breathing circuits due to glued connections that can loosen during ventilation, potentially causing partial or complete detachment of circuit pieces.
Draeger Medical recalls VentStar Watertrap (P) 180 breathing circuit equipment because glued connections can become loose or detach before or during ventilation.
Surgical Innovations Ltd is recalling 2380 YelloPort Elite optical trocars due to inability to guarantee sterility. Patients using contaminated surgical instruments may develop serious infections.