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.
PIES & SIDES Broccoli Casserole by Robeson Enterprises is recalled because the product label does not list ingredients. The product contains wheat, eggs, milk, soy, and fish.
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.
Boston Scientific's EndoVive 20Fr PEG kit may have a blocked connector preventing proper guidewire advancement during placement, potentially requiring emergency intervention.
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.
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.
Synovo Production recalled 496 femoral resurfacing cup components that were marketed without FDA clearance. These hip implant components were distributed in the United States.
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 is recalling 764 acetabular fixation cups marketed without FDA clearance or approval. These hip replacement components were distributed nationwide in Washington state.
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.
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.
Stryker Communications recalls Chromophare Surgical Light Systems due to insufficient mounting force that could compromise the equipment's stability in surgical environments.
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.
Robeson Enterprises is recalling Peach Pie distributed to GA, NC, and SC because the label fails to list sub-ingredients. The recall affects all lots shipped before February 23, 2024.
Robeson Enterprises is recalling Pies & Sides Sweet Potato Casserole because the product label fails to list any ingredients, including egg and milk. Consumers with allergies to these ingredients should not consume the product.
Robeson Enterprises is recalling Pies & Sides Strawberry Pie because the label fails to list sub-ingredients. Consumers with allergies cannot verify safe ingredients. The recall affects Georgia, North Carolina, and South Carolina.
NATCO Pharma Limited is voluntarily recalling 30 bottles of Lansoprazole 15 mg delayed-release capsules due to Current Good Manufacturing Practice deviations. The product was distributed nationwide in the United States.
Robeson Enterprises is recalling 2,984 units of Pies & Sides Connie's Caramel Apple Pie due to incomplete ingredient labeling. The product labels do not list sub-ingredients for prepared components.
Green Bean Casserole recalled by Robeson Enterprises due to missing ingredient labels. Product contains undeclared milk, soy, fish, and wheat allergens.
Robeson Enterprises is recalling cherry pie products because labels do not list sub-ingredients. Products were distributed in Georgia, North Carolina, and South Carolina.
PepsiCo is recalling Schweppes ZERO SUGAR GINGER ALE because the product contains full sugar despite zero-sugar labeling. The recalled product was distributed in Maryland, Pennsylvania, and West Virginia.
Robeson Enterprises is recalling PIES & SIDES DOT'S POTATO BAKE due to incomplete ingredient labeling. The label fails to list sub-ingredients.
SleepNet Corporation is recalling Mojo 2 Full Face Non Vented Masks due to magnets in the device and updated contraindications and warnings. The recall affects 2,107 units distributed worldwide.
SleepNet Corporation is recalling Mojo 2 Full Face CPAP masks (1,268 units worldwide) to update contraindications and warning language due to magnets in the masks. The FDA classified this as a Class I recall.
SleepNet Corporation is recalling 2,787 units of the Mojo 2 Full Face Vented Mask due to updates needed for contraindications and warning language regarding magnets in the device. Worldwide distribution.
SleepNet is updating safety warnings and contraindications for its Mojo Non Vented Full Face Mask due to magnet content. All 11,874 affected units are subject to this warning update.