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.
Zyno Medical LLC is recalling 613 units of the Z-800 Infusion System distributed nationwide because unreleased software versions were installed on the devices without verification or validation.
Philips is recalling certain Intera 1.5T Achieva Nova MRI systems due to a gradient coil component that can overheat, potentially causing smoke or fire with risk of burns, smoke inhalation, or asphyxia.
Tecfen Medical is recalling its 20G (1.2mm) MVR Sideport Knife Straight (Model QKN2312) ophthalmic knives due to sterility assurance concerns. The recall affects 38 units distributed in the US and internationally.
Sysco Corporation is recalling multiple fresh salad products because cucumbers used in the products have the potential to be contaminated with Salmonella. The recall affects salads sold under brands including East Coast Fresh and Created Fresh.
Philips is recalling three Intera 1.5T Achieva Nova-Dual MRI systems worldwide due to a gradient coil component failure that can generate smoke and fire, posing risks including burn injury and asphyxia.
BD Texium closed system drug transfer devices in multiple sizes may leak at the interface between the male luer component and needle-free connector, potentially causing treatment delays, exposure to hazardous drugs, and underdosing.
Lipman Family Farms is recalling Cucumber 5lb cases distributed across 18 states due to potential Salmonella contamination. Consumers should not consume the product and should dispose of it or return it to the retailer.
Lipman Family Farms is recalling sliced cucumbers due to potential Salmonella contamination. The product was distributed across multiple states, and consumers should not consume it.
Sysco Corporation is recalling cucumber products sold under the Imperial Fresh, East Coast Fresh, Just Cut, Wellsley Farms, and other brands due to potential Salmonella contamination. The products were distributed to multiple states and Puerto Rico.
Philips is recalling Intera 1.5T Omni/Stellar MRI systems due to a gradient coil component failure that can produce smoke and fire, risking patient and operator injury or death.
Alembic Pharmaceuticals is recalling Celecoxib 200 mg capsules after a customer found a Tadalafil 5 mg tablet inside a sealed 500-count bottle. The contamination was discovered through a customer complaint.
Philips Achieva XR MRI systems may have a gradient coil component failure that can generate heat, smoke, and fire. The risk to patients and operators includes inhalation of smoke, burns, and asphyxia.
Crystal Creamery Inc. is recalling non fat dry milk due to potential Salmonella contamination. The affected product was distributed in California and Texas.
SAINI TRADE INC is recalling ELECTRO BUZZ dietary supplement (lot KT-1ST-43-01-07/2024, expiring 10/15/2026) distributed nationwide. Laboratory testing found undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.
MALEXTRA Recharge with Extra dietary supplement is being recalled nationwide because laboratory testing found undeclared pharmaceutical ingredients propoxyphenylsildenafil and sildenafil in the product.
Sysco Corporation is recalling Created Fresh Chicken Salad on Everything Ficelle sandwiches due to potential Salmonella contamination from cucumbers used in the product.
Covidien is recalling Newport HT70 and HT70Plus ventilators due to capacitor failures that may cause the device to shut down unexpectedly or fail to alarm, risking respiratory failure and oxygen deprivation in patients.
Microtek Medical is recalling Patient Drape adapter plug kits (models AP6MMN and AP8MMN) because non-sterile products were labeled as sterile. The affected adapters are used to connect drain hoses to fluid management devices.
Philips is recalling one Intera 1.5T Explorer/Nova Dual MRI system due to a gradient coil component that may overheat, produce smoke, or ignite, risking patient and operator injury.
Male Ultra dietary supplement, distributed nationwide in 3,000 boxes, has been recalled because laboratory testing found it contains undeclared pharmaceutical ingredients: propoxyphenylsildenafil and sildenafil. The product was marketed without FDA approval.
Zyno Medical LLC is recalling the Z-800F Infusion System because unreleased software versions were installed on distributed devices without verification or validation. This poses a risk to patients receiving intravenous infusion therapy.
Lipman Family Farms is recalling Cucumber Super Selec products due to potential Salmonella contamination. The affected cucumbers were distributed across multiple states.
TGD Cuts, LLC is recalling Cucumber Sliced/Grape Tomato 50/2oz. packs due to Salmonella contamination. The product was distributed to Maryland, Pennsylvania, North Carolina, Virginia, and New Jersey.
Male Ultra Pro capsules are being recalled because laboratory testing found undeclared propoxyphenylsildenafil and sildenafil. The product was marketed without an approved New Drug Application.
Sysco Corporation is recalling East Coast Fresh Greek Pasta Salad Kits due to potential Salmonella contamination in cucumbers. No illnesses have been reported.