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.
Tasty-Sawa ground cinnamon in 55.11-pound bags distributed in Florida, Georgia, North Carolina, Trinidad and Tobago, and Guyana is being recalled due to elevated lead levels. Consumers should stop using this product immediately.
ConvaTec is recalling 63 market units of CarboFlex odor control dressings that fail to meet sterility assurance requirements. Affected lots were distributed in six states.
Synovo Production is recalling 764 acetabular fixation cups marketed without FDA clearance or approval. These hip replacement components were distributed nationwide in Washington state.
Nicomex Inc. is recalling Nicomex Tequesquite seasoning (1.5 oz) due to elevated lead levels. Approximately 192 units were distributed to retailers in New Jersey and New York.
Boston Scientific's EndoVive 20Fr PEG kit may have a blocked connector preventing proper guidewire advancement during placement, potentially requiring emergency intervention.
Lupin Pharmaceuticals recalls Rifampin Capsules USP 300mg nationwide due to subpotency—the drug contains less active ingredient than labeled. Affected lot: A201064, expiring March 2024. 26,352 bottles involved.
Taylor Farms is recalling a Buffalo Chicken Party Tray because the product's bottom tray is mislabeled as a different salad, failing to declare the presence of milk, wheat, and soy. The recall affects 64 units distributed in Oregon and Washington.
Synovo Production recalled 496 femoral resurfacing cup components that were marketed without FDA clearance. These hip implant components were distributed in the United States.
Boston Scientific is recalling EndoVive 20 Fr feeding tubes due to potential blockage during placement that may prevent guidewire advancement. This could lead to procedure complications including bleeding, gastric leakage, or aspiration.
Medline is recalling 79 Bed Assist Bars that failed to comply with federal safety standards for adult portable bed rails. The products were manufactured after the compliance deadline.
Teva Pharmaceuticals recalls Isotretinoin 40mg capsules for exceeding specification limits in potency. No illnesses reported.
Taylor Farms Southwest recalled 150 units of chicken caesar salad mislabeled as garden salad, with undeclared allergens including egg, fish, and soy. Affected product was distributed in Arizona, Colorado, New Mexico, Nevada, Utah, and Texas.
Qiagen Sciences is recalling 168 units of the EZ2 Connect MDx-IVD nucleic acid isolation device due to insufficient welding that causes heater cable embrittlement and device malfunction, resulting in sample loss during testing.
Tuna salad sandwiches were mislabeled as egg salad, creating an undeclared fish allergen risk for consumers. The recall affects 551 units distributed to institutions and retailers across ten states.
Boston Scientific's EndoVive 20Fr PEG Kit may have a blocked connector that prevents the guidewire from advancing during placement, potentially causing complications including bleeding and aspiration.
Pueblo Fruits is recalling 23 cases of yellow onions sold to a single restaurant in Albuquerque because the firm did not complete a hazard analysis for potential Clostridium botulinum growth in vacuum-sealed bags.
RayStation radiation therapy planning software versions 8B through 2024A contain a use error that can incorrectly select silicon material for silicone gel polymer implant dose calculations, potentially resulting in incorrect radiation doses.
Lidl is recalling Deluxe Macarons Party Edition due to undeclared allergens. The packaging is labeled in a foreign language and does not identify wheat, soy, egg, milk, and tree nuts.
Synovo Production is recalling 1,681 acetabular bearing components that were marketed without FDA clearance.
Intuitive Surgical recalled 53 da Vinci SP Surgical System Patient Carts due to inadequate welds in the instrument arm joints. These welds may cause tissue injuries, conversion to open surgery, or user pinching injuries.
RAJA FOODS LLC is recalling SWAD BRAND CINNAMON POWDER (3.5 oz) after testing confirmed lead contamination. The affected batch should not be consumed.
Stryker Communications recalls Chromophare Surgical Light Systems due to insufficient mounting force that could compromise the equipment's stability in surgical environments.
Boston Scientific is recalling the EndoVive 20Fr PEG feeding kit due to blockage in the barb connector that can prevent proper placement. The blockage may lead to prolonged procedures, bleeding, gastric leakage, and aspiration risk.
Baxter Healthcare is recalling Connex ProBP 3400 blood pressure monitors due to power cord insulation defects that fail to meet electrical safety standards. Approximately 11,154 units are affected globally.
Robeson Enterprises is recalling Pies & Sides Hashbrown Casserole because the label lacks an ingredient list, preventing consumers from identifying allergens. The product was distributed in Georgia, North Carolina, and South Carolina.