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.
Burlington Medical is recalling wrap aprons made with Xenolite 800 attenuation material because of the potential for attenuation degradation over time.
Medline is recalling four bronchoscopy and laryngoscopy kits because they contain recalled Olympus biopsy valves, where rubber fragments may detach from the valve slit during use.
Civco is recalling the eTRAX Needle Sensor 12G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.
Mentor is recalling CPX 4 US Breast Tissue Expanders with Suture Tabs in the SILTEX low height range because the infusion sets may contain a dull or blunt needle tip.
Olympus is recalling SOLTIVE Premium SuperPulsed Laser Systems because a potential defect in the 24V power supply module may render the system inoperable and produce smoke or a burning smell.
Burlington Medical is recalling leg wraps because of the potential for attenuation degradation over time, decreasing the lifespan of the product.
Quality Choice Moisturizing Relief Eye Drops, containing dextran 70, polyethylene glycol 400, povidone and tetrahydrozoline hydrochloride, are being recalled for lack of assurance of sterility.
Burlington Medical is recalling half aprons because of the potential for attenuation degradation over time, decreasing the lifespan of the product.
Philips is recalling the Allura Xper FD10F because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
GNP Eye Drops Redness and Dry Eye Relief, containing glycerin and naphazoline hydrochloride, are being recalled for lack of assurance of sterility.
Medtronic is recalling Paradigm REAL-Time Veo insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.
Philips is recalling the Allura Xper FD10/10 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Intuitive Surgical is recalling da Vinci S and Si Grasping Retractor Instruments following increased complaints of broken or frayed grip cables in reusable instruments.
Medline is recalling three bronchoscopy convenience kits because they contain recalled Olympus biopsy valves, where rubber fragments may detach from the valve slit during use.
Medline is recalling the Airway Exam Kit because it contains recalled Olympus biopsy valves, where rubber fragments may detach from the valve slit during use.
Ultradent Products is recalling one lot of Jiffy Original Composite Polisher Cups because the cups may crumble and break apart easily, which could delay patient treatment.
Medtronic is recalling MiniMed 530G insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.
Medtronic is recalling MiniMed 780G insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.
Medtronic is recalling Paradigm insulin pumps models MMT-712 and MMT-715 because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.
Medline is recalling the Anterior Hip Pack because it contains recalled Olympus biopsy valves, where rubber fragments may detach from the valve slit during use.
Burlington Medical is recalling demi half aprons because of the potential for attenuation degradation over time, decreasing the lifespan of the product.
Philips is recalling the Allura Xper FD20 Biplane because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Burlington Medical is recalling blockers because of the potential for attenuation degradation over time, decreasing the lifespan of the product.
Civco is recalling the eTRAX Needle System Starter Kit 12G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.
Medline is recalling Thoracic Robots kits, model DYNJ908777B, because they contain recalled Olympus biopsy valves where rubber fragments may detach from the valve slit.