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.
Civco is recalling the eTRAX Needle Sensor 16G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified on the user interface.
Burlington Medical is recalling kilts made with Xenolite 800 attenuation material because of the potential for attenuation degradation over time.
Medtronic is recalling MiniMed 720G 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 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Philips is recalling the Allura Xper FD10C because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Mentor Texas is recalling Artoura Breast Tissue Expanders because the infusion sets may contain a dull or blunt needle tip that may be difficult to advance or may break.
K.C. Pharmaceuticals is recalling Sterile Eye Drops Soothing Tears, sold as Rugby Lubricating Eye Drops and Walgreens Lubricant Eye Drops, for lack of assurance of sterility.
One Paradise Ultrasound Renal Denervation catheter was distributed although it was a nonconforming product that should have been scrapped and not used in humans.
Medtronic is recalling MiniMed 740G 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 Vue Motion V12 because mis-ordered frames during dynamic cine runs may cause image frames to display out of sequence.
Intuitive Surgical is recalling da Vinci S and Si Monopolar Curved Scissors Instruments following increased complaints of broken or frayed grip cables in reusable instruments.
RefleXion Medical is recalling the X1 Radiotherapy System because a software defect can mean angular roll corrections are not carried through to treatment delivery.
Burlington Medical is recalling kilt blockers because of the potential for attenuation degradation over time, decreasing the lifespan of the product.
HEYTEA USA INC is recalling Coconut Drink 1 (1L cartons) because the product contains undeclared milk. Consumers with milk allergies or sensitivities are at risk.
Medtronic is recalling MiniMed 640G 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 OR Table because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
One lot of Sterile Radiology Procedure Kits, model DYNDH1491B, is being recalled because of a potential breach in the sterile pouch packaging that may compromise sterility.
SIGNA Premier MRI systems are being recalled because they may have been built or serviced with ferrous steel fittings instead of non-ferrous brass on the magnet rear.
Civco is recalling the eTRAX Needle Sensor 18G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.
Philips is recalling the Allura Xper FD20/15 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Medline is recalling ENFit G-tube connectors because they were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices.
Five lots of Prazosin Hydrochloride tablets are being recalled after detection of the nitrosamine impurity N-nitroso-prazosin impurity C above acceptable limits.
Medtronic is recalling Paradigm REAL-Time Revel insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.
TG FOODS INC is recalling Divided Sunset Multi Collagen Peptides (8 oz) because the product contains eggshell membrane collagen and wild-caught marine collagen but fails to declare EGG and the specific fish species on the label.
Imu-Tek Animal Health is recalling Imu-Tek Colostrum-5 120 Capsules (Lot #013, Expiration 092826) because the product is potentially under-processed. The product was distributed across 29 states.