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.
Breckenridge Pharmaceutical recalls 14,749 bottles of duloxetine 30mg delayed-release capsules due to N-nitroso impurity above FDA safety limits. Patients taking this medication should contact their healthcare provider to verify if their prescription is affected.
HEB is recalling Spinach Artichoke Dip sold in Texas due to potential metal contamination. Consumers should not consume the affected products.
Multiple brands of soup and oyster crackers are being recalled due to potential stainless steel wire. The affected products were distributed across 24 states.
Chicken of the Sea is recalling 14,147 cases of Van Camp's Solid Light Yellowfin Tuna due to improperly secured easy-pull lids that may allow Clostridium botulinum contamination. No illnesses have been reported.
Stiebs, LLC is recalling Organic Acai Bowls due to potential contamination with blue plastic pieces. Affected products were distributed in six states.
ZOLL is recalling certain Powerheart G5 automated external defibrillators (AED) due to the potential for devices to fail their self-test when exposed to extreme temperatures or humidity.
TruAbutment Inc. recalls 61 units of the TruScan Body dental scanner (CN38-SB) due to defects that may prevent proper or accurate scanning.
GE Healthcare Revolution CT and Apex series imaging systems may leak blue coolant fluid near the gantry base, creating a potential slip and fall hazard. Approximately 250 units have been distributed worldwide.
DePuy Mitek is recalling COR Disposable Kit cartilage transplant systems because some units lack the pin in the graft loader component. The manufacturing defect may prevent proper device function during surgical use.
Cordis US Corp is recalling Vista Brite Tip guiding catheters manufactured at incorrect length. The defect may affect proper catheter placement during interventional or diagnostic vascular procedures.
Ulker Dankek Roll Cake Chocolate is being recalled because egg is not listed in the Contains statement on the product label. Consumers with egg allergies may be at risk.
Trader Joe's Solid White Albacore Tuna (5 oz cans) is being recalled due to improperly secured lids that may allow contamination with Clostridium botulinum. Affected products have Best By dates of 01/08/2028 or 01/09/2028.
Danone is recalling Hazelnut International Delight Coffee Creamer due to reported spoilage and illness complaints. The product was distributed to 30 states.
Trader Joe's Solid White Albacore Tuna in Water is being recalled because improperly secured easy-pull lids may allow contamination with Clostridium botulinum.
Intuitive Surgical has recalled 439 Da Vinci 5 surgical console foot tray pedals due to spring failures that can cause pedals to remain pressed and interfere with normal surgical robot operation.
Chicken of the Sea recalls Genova branded solid white tuna nationwide due to improperly secured easy-pull lids that may allow Clostridium botulinum contamination.
Aesculap is recalling 47,078 surgical forceps designed to control bleeding. The devices' clamps break when used outside design parameters, potentially compromising their effectiveness.
The ZOLL Powerheart G5 automated external defibrillator may fail its self-test after prolonged exposure to extreme temperatures or humidity levels. This could prevent proper device functioning in an emergency.
GE Healthcare Revolution CT systems may leak glycol coolant near the gantry base. While the non-toxic fluid poses no chemical hazard, it creates a slip-and-fall risk if not noticed and cleaned.
GE Healthcare is recalling 21 Revolution CT and Revolution Apex series CT systems due to potential coolant fluid leaks near the gantry base. The leaking fluid poses a slip-and-fall hazard if not cleaned up promptly.
ZB Importing LLC is recalling Ulker Dankek Roll Cake Banana due to wheat allergen not being listed in the product label. Consumers with wheat allergies or celiac disease should not consume this product.
ZB Importing LLC is recalling Ulker Dankek Roll Cake Strawberry because milk is not declared on the label. Products were distributed in multiple US states and Ontario, Canada.
Genova branded Yellowfin Tuna cans are being recalled because the easy-pull lid was not properly secured, which may cause Clostridium botulinum contamination. The recall affects 14,147 cases distributed nationwide with best-by dates from December 2027 through January 2028.
Danone US is recalling Cinnabon Classic Cinnamon Roll International delight Coffee Creamer due to complaints of spoilage and illness. The product was distributed to 30 states.
Genova branded Yellowfin Tuna in Extra Virgin Olive Oil is being recalled because its easy-pull lid may not be properly secured, potentially allowing clostridium botulinum contamination.