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.
Dakota Toms Pepperjack Cheese Burgers are recalled for potential Listeria monocytogenes contamination. Affected products expire between 9/1/24 and 11/28/24.
GE Healthcare Giraffe Omnibed infant incubators may release airborne formaldehyde when newly manufactured. Customers were notified in June 2023 to run units for one week to reduce potential off-gassing.
Maquet Cardiovascular is recalling the VasoView HemoPro Endoscopic Vessel Harvesting System due to silicone detachment from the Harvesting Tool Jaws during use. This FDA Class I recall affects 28,809 units worldwide.
ImaCor is recalling 73 ClariTEE Probe ultrasound units due to defective epoxy sealing that could degrade diagnostic image quality. The affected units were distributed in Florida, Georgia, New Jersey, and Tennessee.
Accord Healthcare is recalling Cinacalcet 90 mg tablets nationwide due to nitrosamine impurity (N-nitroso-cinacalcet) at levels exceeding the FDA's acceptable daily intake limit. The issue stems from manufacturing process deviations.
BLI International is recalling Chlorpheniramine Maleate 4 mg tablets because the product failed stability testing, showing increased potency beyond specified limits. The recall affects 4,901 cases distributed to customers in Ohio and Missouri.
Integra LifeSciences is recalling surgical patties and strips (Model 801409) used in surgery due to higher-than-expected endotoxin levels detected in raw materials. No illnesses have been reported.
Integra LifeSciences is recalling Codman Surgical Patties and Strips (Model 801400) due to higher-than-expected endotoxin levels in raw materials that resulted in out-of-specification finished products.
Hillrom Centrella Smart+ hospital beds may fail to send remote alerts through the Rauland Responder 5 Nurse Call System, though local bed alerts still function. This could delay nursing staff notification of patient needs.
Integra LifeSciences is recalling surgical patties and strips due to higher-than-expected endotoxin levels in raw material that may result in out-of-specification finished products. The recall affects 2,056 units distributed worldwide.
Accord Healthcare recalls Cinacalcet 60mg tablets nationwide because N-nitroso-cinacalcet impurity was detected above acceptable daily intake limits. The contamination resulted from manufacturing process deviations.
Codman Surgical Patties and Strips are being recalled due to higher-than-expected endotoxin levels in raw materials. Approximately 93,782 units were distributed worldwide for use in protecting tissue during surgery.
Integra LifeSciences recalls 1,222 Surgical Patties and Strips (Model 801455) due to elevated endotoxin in raw material, which may contaminate finished products used to protect tissue during surgery.
Reser's Fine Foods recalled Bistro 28 Chicken Street Tacos Express Meal Kits due to Listeria monocytogenes in the cooked chicken. The recall affects 2,880 cases distributed across 31 states.
Abbott is recalling 13,318 units of its Alinity m HPV AMP Kit due to iron leaching into the lysis solution, causing positive controls to fail and potentially producing false negative test results.
Integra LifeSciences Corp. is recalling surgical patties and strips (Model 801402) used in surgery due to higher-than-expected endotoxin levels in raw materials that may affect the finished product.
Physio-Control is recalling 105 LIFEPAK 15 monitor/defibrillator systems due to a manufacturing defect caused by an out-of-tolerance tool used during assembly. Affected units were distributed in Connecticut, Georgia, Massachusetts, New York, Ohio, Washington, and West Virginia.
Integra LifeSciences has recalled Codman surgical patties and strips due to higher-than-expected endotoxin levels in raw materials, which may result in out-of-specification endotoxin in finished products.
Dr. Reddy's Laboratories is recalling Cinacalcet 90 mg tablets due to N-nitroso impurity exceeding FDA limits. Patients should contact their healthcare provider.
Integra LifeSciences is recalling Surgical Patties and Strips (Model 801457) due to higher-than-expected endotoxin levels in raw materials. These surgical devices protect tissue during operations, including brain and nervous system procedures.
The AVOXimeter 1000E blood oximeter (Serial Number 6824) has calibration values that are higher than normal, causing false oxygen level readings. This may lead to patient care mismanagement based on inaccurate data.
Nihon Kohden America is recalling its Adult/Pediatric Forehead Disposable SpO2 Sensor (Model 809030006) because the device was distributed without FDA market approval or clearance.
Integra LifeSciences is recalling surgical patties and strips (Model 801451) worldwide due to higher-than-expected endotoxin levels in raw materials that may result in out-of-specification contamination.
Glaser Organic Farms recalls All Raw Vegan Certified Organic Salsa due to potential glass contamination. The product may pose a risk of injury to consumers.
Abbott is recalling Alinity m STI and HPV test kits due to iron leaching that invalidates quality control checks, potentially compromising test result reliability.