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.
Olympus is recalling 9 bronchoscopes (Models BF-P150 and BF-1T150) due to complaints of endobronchial combustion during therapeutic laser procedures. The defect could cause fire and serious burn injuries.
Abiomed recalls Impella LD blood pumps due to potential interaction with aortic valve replacement devices that can damage the pump impeller and cause blood clots. Patients with these devices should contact their healthcare provider.
Walmart's Great Value Mixed Fruit is recalled for potential Listeria monocytogenes contamination. The FDA issued a Class I recall affecting approximately 70,360 cases distributed nationwide.
Aldi's Seasons Choice frozen tropical fruit blend is being recalled due to potential Listeria monocytogenes contamination. No illnesses have been reported.
Townsend Farms' Private Selection frozen blueberries, strawberries, and mangoes are recalled due to potential Listeria monocytogenes contamination. Approximately 34,944 bags were distributed across 16 U.S. states.
SunOpta's frozen mango chunks sold nationwide under Great Value and Good & Gather brands are recalled due to potential Listeria monocytogenes contamination. No illnesses have been reported.
The Cardiosave Hybrid Intra-Aortic Balloon Pump may lose the ability to charge batteries in one or both bay slots, potentially interrupting critical therapy if disconnected from AC power. Low battery alarms may alert users before therapy is interrupted.
Abiomed's Impella 5.0 intravascular blood pump is recalled due to risk of impeller blade destruction when interacting with heart valve replacements. The damaged pump can cause reduced blood flow and potentially release fractured material into the bloodstream.
Townsend Farms is recalling Private Selection frozen strawberry, mango, and pineapple smoothie blend due to potential Listeria monocytogenes contamination. The product was distributed across 16 states.
Aldi's Seasons Choice Mixed Fruit is being recalled nationwide due to potential contamination with Listeria monocytogenes. Affected lot codes are FMX227603, FMX227604, and FMX227605.
The Cardiosave Rescue Intra-Aortic Balloon Pump may lose battery charging ability in one or both bays, potentially interrupting therapy if disconnected from power. Low battery alarms may alert users before therapy stops.
Abiomed is recalling the Impella 5.5 with SmartAssist pump due to a risk of impeller blade destruction when used with aortic valve replacement devices. Damage can result in low blood flow and systemic embolization, where broken pump pieces may enter the bloodstream.
SunOpta's Good & Gather brand frozen mixed fruit blend is recalled nationwide due to potential Listeria monocytogenes contamination. Affected consumers should not consume this product and should return it to the retailer.
Scenic Fruit Company recalls Cadia and Trader Joe's frozen pineapple products due to potential Listeria monocytogenes contamination. Consumers should not consume the recalled items.
Trader Joe's Organic Tropical Fruit Blend frozen fruit is being recalled nationwide due to potential Listeria monocytogenes contamination affecting 2,588 cases.
Impella 2.5 intravascular blood pumps may experience unintended interaction with aortic valve replacement stents, damaging impeller blades and reducing blood flow. Fragments may circulate through the bloodstream.
Olympus BRONCHOVIDEOSCOPE Model BF-Q170 is recalled nationally due to complaints of endobronchial combustion during therapeutic laser procedures, classified as FDA Class I.
Good & Gather Triple Berry Blend, sold at Target, is being recalled nationwide due to potential Listeria monocytogenes contamination. Consumers should not consume the affected product.
Trader Joe's Organic Tropical Fruit Blend is recalled due to potential contamination with Listeria monocytogenes from pineapple ingredients. The 16 oz. bags were distributed nationwide.
SunOpta Grains and Foods Inc. is recalling nationwide frozen pineapple chunks sold under the 365 Whole Foods Market and Bulk Organic brands due to potential Listeria monocytogenes contamination.
Abiomed's Impella CP cardiac pump can be damaged by interaction with replacement heart valves, potentially causing blood clots. The FDA classified this as a Class I recall of 9,252 units worldwide.
Olympus is recalling OES Bronchofiberscope models due to reports of combustion during laser procedures. This poses a serious burn injury risk to patients.
Townsend Farms is recalling Private Selection 48oz Classic Fruit Medley due to potential contamination with Listeria monocytogenes. The frozen product was distributed across 16 states.
The FDA recalls 284 Olympus EVIS EXERA bronchoscopes due to complaints of combustion during therapeutic laser procedures. Users should stop using affected models immediately.
Frito-Lay is recalling Tostitos Avocado Salsa Jar Dip (15 oz, UPC 2840005597) because certain jars contain undeclared milk allergen. Approximately 100,980 jars were distributed in all 50 states with best-by dates of 2 NOV 23 or 3 NOV 23.