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.
Alprostadil 3.0 gm is being recalled due to manufacturing practice deviations. Limited distribution affects product with lot number HAALC0020922 (expiration August 2025).
Aspen Biopharma Labs is voluntarily recalling Chlorambucil due to manufacturing process deviations. The product was distributed to distributors in Hong Kong and Florida.
ZOLL is recalling 8,744 Powerheart G5 AED units that may fail their self-test if exposed to extreme temperatures or humidity, potentially masking device malfunctions.
DePuy Mitek's COR Disposable Cartilage Transplant System is being recalled because some units are missing a pin in the graft loader component, which could affect surgical function.
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to a mechanical defect in the wash wheel mixer that may prevent the device from operating properly. The defect can cause test delays or cancellation.
Aspen Biopharma Labs is recalling Latanoprost medication due to manufacturing practice deviations. The voluntary recall affects product distributed to distributors in Hong Kong and Florida.
Trader Joe's Solid White Albacore Tuna is being recalled because the easy-pull lid may not be properly secured, risking contamination with botulism bacteria.
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.
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.
Aesculap is recalling 1,147 hemostatic forceps due to clamp breakage risk when used beyond design specifications. Units were distributed nationwide and internationally to healthcare providers.
Chattem Inc. is recalling Unisom SleepMelts diphenhydramine HCl 25 mg tablets nationwide due to a nitrosamine impurity detected above FDA's acceptable daily intake limit. Affected lots expire between May 2025 and April 2026.
Multiple brands of soup and oyster crackers are being recalled due to potential stainless steel wire. The affected products were distributed across 24 states.
Danone is recalling Hazelnut International Delight Coffee Creamer due to reported spoilage and illness complaints. The product was distributed to 30 states.
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.
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.
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.
ZOLL Powerheart G5 AED devices may fail their self-test if exposed to extreme temperatures or humidity. Approximately 56,981 units are being recalled nationwide and internationally.
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.
ZOLL is recalling certain Powerheart G5 AED units that may fail their self-test when exposed to extreme temperatures or humidity. The affected devices could fail to function properly in emergencies.
Trader Joe's Solid White Albacore Tuna in Water is being recalled because improperly secured easy-pull lids may allow contamination with Clostridium botulinum.
HEB is recalling Spinach Artichoke Dip sold in Texas due to potential metal contamination. Consumers should not consume the affected products.
Stiebs, LLC is recalling Organic Acai Bowls due to potential contamination with blue plastic pieces. Affected products were distributed in six states.
CardioFocus is recalling 833 units of CardiFocus Heartlight X3 cardiac catheters due to potential damage to the sterile barrier pouch that could compromise product sterility. Affected units were distributed worldwide.
TruAbutment Inc. recalls 61 units of the TruScan Body dental scanner (CN38-SB) due to defects that may prevent proper or accurate scanning.
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.