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.
Grecian Delight and Sysco Classic tzatziki sauce may contain Salmonella. Consumers should discard the product or return it to their retailer.
US Foods Chef's Line and Nick The Greek tzatziki products distributed across multiple states are being recalled due to potential salmonella contamination. Consumers should not consume these products.
Maquet Cardiovascular is recalling the Vasoview Hemopro 2 Vessel Harvesting System due to potential heater wire and silicone defects. These could affect device function during minimally invasive surgery.
Grecian Delight/Kronos is recalling Nick The Greek Spicy Yogurt Pails (Lot 4305) due to potential salmonella contamination. The 42-lb pails were distributed across 27 U.S. states.
Olympia Foods has recalled Grecian Dip Tzatziki sauce due to potential Salmonella contamination. Consumers should not consume affected products and should check lot codes before use.
Herbal capsules sold nationwide have been recalled after the FDA found undeclared medications inside. The product contained furosemide, dexamethasone, and chlorpheniramine without proper labeling.
Fresenius Kabi is recalling 1,520 Ivenix infusion pumps (model LVP-0004) due to potential pneumatic valve failure that may stop active infusions or prevent pump operation. Affected units were distributed to healthcare facilities in six U.S. states.
FDA recalls VasoView HemoPro 2 endoscopic vessel harvesting systems due to risk of heater wire detachment and silicone peeling from the harvesting tool jaws, which could affect device function.
Endo USA is recalling approximately 9,816 cartons of Clonazepam 2 mg tablets due to incorrect strength labeling on the carton exterior. The blister strips inside contain the correct formulation.
Endo USA, Inc. is recalling 22,513 cartons of clonazepam tablets due to incorrect strength labeling on some carton exteriors. The actual tablets inside have correct labeling.
Endo USA recalls clonazepam tablets because some cartons are labeled with incorrect declared strength. The medication inside the blister strips contains the correct strength.
Dairyland Produce is recalling 4 cases of Texas Harvest cucumbers due to potential Salmonella contamination. Consumers should not consume the affected product.
The JMC5A Ni/TruAire-5 Oxygen Concentrator (Model O2C5L) is being recalled. The device may catch fire or melt during use, creating a risk of serious injury from fire and burns.
Amerisource Health Services LLC is recalling Clobazam 10 mg tablets due to the presence of foreign tablets or capsules in some packages. The recall affects 5,178 cartons with Lot #1019594 distributed nationwide.
Stryker's Neptune 3 and Neptune S Rover surgical suction systems are recalled due to improperly tightened bolts on the vacuum pump filter housing. Loose bolts may cause loss of suction force during medical procedures.
Aerin Medical is recalling 479 units of VivAer Stylus (Lot #10235) due to incorrect programming in units from a single lot. When connected to the Aerin Console, affected devices will be incorrectly identified as RhinAer Stylus.
Elucent Medical is recalling the EnVisio Patient Pad Transition Cushion due to a potential safety risk of the surgical bed frame's back section detaching during use. Approximately 283 units are affected across 16 U.S. states.
Applied Medical Technology is recalling AMT Mini Enteral Extension Sets due to incorrect ENFit connector type. Affected units have ENFit connections instead of non-ENFit, preventing proper compatibility with intended systems.
Fresenius Medical Care is recalling Dialyzer Optiflux 160NRe units nationwide due to potential internal blood leaks caused by cracked polyurethane in the dialyzer material.
Rising Pharma is recalling 73,680 bottles of Duloxetine 20 mg capsules nationwide due to N-nitroso-duloxetine impurity above recommended limits from manufacturing deviations. No illnesses have been reported.
Spacelabs Healthcare's Xhibit Telemetry Receiver (Model 96280) may experience a Windows proxy issue causing the system to restart and go offline for 1-1.5 minutes, creating a temporary gap in patient monitoring.
GE Healthcare Optima XR200amx mobile radiographic systems may have missing bolts in the Column Safety mechanism, which could allow the X-ray arm to drop if an internal cable fails.
Certain Tec 6 Plus and Tec 800 series anesthesia vaporizers may deliver less anesthetic agent than the dial setting indicates due to a manufacturing issue. Approximately 1,573 units are affected, distributed in the United States and globally.
GE Medical Systems recalls Tec 850 SEV anesthesia vaporizers due to a manufacturing defect that may cause them to deliver less anesthetic agent than the dial setting indicates. Affected devices distributed nationwide and globally.
Eugia US LLC is recalling Progesterone Injection due to a market complaint of glass particles found in vials. The affected batch poses a potential risk to patients who receive injections from contaminated vials.