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.
ICU Medical is recalling 16,850 ChemoLock Universal Vented Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.
Alcon Research is recalling 25,778 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.
Surgical Theater is recalling 50 units of its PE SNAP imaging platform because a software anomaly may misalign secondary image layers against the primary layer.
Fresenius Kabi is recalling six Ivenix Infusion System large volume pumps over a potential issue causing the device to register phantom touches in the lower-left corner of the touchscreen.
Microgenics is recalling 4,462 units of Thermo Scientific MAS Omni CARDIO control after customers reported vial-to-vial variability with high sensitivity Troponin I assays.
ICU Medical is recalling 11,200 ChemoLock Vented Vial Spikes, 20mm, because the port weld of the drug transfer device may separate or break during use and leak.
FarmaKeio Outsourcing is recalling 529 sterile Testosterone 87.5 mg pellets from one lot over the potential presence of metal particulate matter.
Breckenridge Pharmaceutical is recalling 172,263 bottles of Duloxetine Delayed-Release Capsules 60 mg because N-nitroso-duloxetine was above the 12.5 ppm safety assessment limit.
Amerisource Health Services is recalling 3,410 unit dose cartons of Prazosin Hydrochloride Capsules 5 mg over N-nitroso Prazosin impurity C above the acceptable intake limit.
Surgical Theater is recalling three units of its SpineAR SyncAR SNAP orthopedic augmented reality platform because a software anomaly may misalign secondary image layers.
Alcon Research is recalling six accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.
Philips Medical Systems is recalling one Incisive CT for Brazil SKD unit on software versions 5.1.0.X and 5.1.1.X over six software issues, including unintentional gantry and couch movement.
Heritage Pharmaceuticals is recalling 5,880 bottles of Desipramine Hydrochloride Tablets USP 50 mg because N-Nitroso Desipramine exceeded the permissible acceptable daily intake level.
Surgical Theater is recalling 45 units of its SuRgical Planner because a software anomaly may misalign secondary image layers against the primary layer.
ProRx is recalling 2,805 vials of Semaglutide Injection 5 mg/2 mL from one lot for lack of assurance of sterility.
Trividia Health is recalling 601 Good Neighbor Pharmacy TRUE METRIX blood glucose meters over a display defect that can cause glucose values to be misread.
Surgical Theater is recalling 17 units of its Surgical Navigation Advanced Platform because a software anomaly may misalign secondary image layers against the primary layer.
ProRx is recalling 8,400 vials of Semaglutide Injection 10 mg/4 mL for lack of assurance of sterility.
Heritage Pharmaceuticals is recalling 8,754 bottles of Desipramine Hydrochloride Tablets USP 25 mg because N-Nitroso Desipramine exceeded the permissible acceptable daily intake level.
CareFusion is recalling 443 BD Pyxis CII Safe ES Tower Main units because potential fluid ingress of the anesthesia or med station may result in smoke, system downtime and/or fire.
ICU Medical is recalling 9,004 ChemoLock Vented Vial Spikes, 13mm, because the port weld of the drug transfer device may separate or break during use and leak.
FreshRealm is recalling 3,428 units of Marketside Cheesy Cauliflower Au Gratin, 12 oz, over potential contamination with Listeria monocytogenes.
ICU Medical is recalling 6,150 ChemoLock Closed Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.
ICU Medical is recalling 950 21-inch extension sets with ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.
ICU Medical is recalling 1,700 Graduated Connectors with ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.