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.
Vitality male enhancement dietary supplement recalled nationwide. Product contains undeclared prescription drugs sildenafil and tadalafil not disclosed to consumers.
Lyons Magnus LLC is recalling Ready Care Chocolate Shake Plus (4 oz) due to potential Listeria monocytogenes contamination. The recall affects 763,250 cases distributed to long-term care facilities, skilled nursing homes, and hospitals.
Smiths Medical is recalling 1961 units of ProPort Plastic Implantable Ports worldwide due to a manufacturing defect that may cause the port housing and reservoir to separate. This Class I recall affects patients dependent on venous access systems.
Berry Buddies fruit-and-pancake cups are being recalled because the back label does not list wheat and eggs as allergens. People with allergies to these ingredients could have serious reactions.
Smiths Medical is recalling its ProPort Plastic Venous Access System due to a manufacturing defect that may cause the plastic port housing and reservoir to separate, affecting 1,695 units distributed worldwide.
The VERICIS Merge Cardio system may display inconsistent cardiovascular measurements in patient reports when specific workflows are used. This could affect clinical decisions based on the reported data.
Brainlab's Origin Data Management software versions 3.1.0 through 3.2.1 may automatically merge patient records from unrelated individuals without user notification, creating a risk of incorrect patient data being used in clinical care.
Prep'd CDA LLC is recalling Chocolate Peanut Butter Protein Balls due to undeclared soy lecithin and undeclared food color additives. Consumers with soy allergies should not consume the product.
Medline is recalling 1,482 units of Proxima sterile surgical drapes due to potential breaches in pouch packaging that could compromise sterility. No illnesses have been reported.
Chef's Line US Foods black bean burgers are being recalled because a bolt was found in the product. The recalled product was distributed to Illinois, Maryland, New Jersey, Pennsylvania, and Delaware.
American Contract Systems Inc is recalling 106 SPINE LUMBAR PACK kits (Models UTSL72AA, UTSL72AB) because the manufacturer cannot confirm sterilization assurance requirements were met, potentially causing functionality loss and treatment delays.
B. Braun Medical is recalling Introcan Safety 3 IV catheters because the valve housing may detach, causing fluid leakage. Approximately 28,200 units are affected.
Dairy State Foods Inc is recalling emd Oysterettes oyster crackers due to the possibility of metal contamination. Affected batches have date codes 34824 and 35324 and were distributed in Michigan.
Medline Industries is recalling Proxima Drape sterile surgical drapes due to potential breaches in pouch packaging that could compromise sterility. The recall affects 2,422 units distributed nationwide.
Microstream CO2 sampling lines may be difficult to disconnect from endotracheal tubes, potentially delaying treatment or causing unintended tube removal.
Merge Healthcare's VERICIS Merge Cardio cardiovascular information system may display inconsistent measurements under specific workflows involving ultrasound remeasurement or manual measurement editing. No illnesses have been reported.
American Contract Systems Inc is recalling 170 Diagnostic Neuro IR Tray kits due to inability to confirm sterilization assurance requirements were met. The units may lose functionality and cause treatment delays.
Immuno-Mycologics' Candida ID Antigen may have reduced sensitivity, causing false negative diagnostic results. Lot F4171005 has been distributed worldwide including CA and OK.
Amgen recalls 258,750 vials of Neupogen (filgrastim) injection due to stability concerns. Stability data shows products may be out of specification at expiration; patients should consult healthcare providers about affected lots.
American Contract Systems recalls 40 kits of Thoracic Packs (Models UTTC82Y and UTTC82AA-01) due to inability to confirm sterilization assurance was met. Unsterilized packs may lose functionality and delay emergency treatment.
American Contract Systems Inc is recalling TOTAL HIP PACK models SMTH06O and SMTH06P due to inability to confirm sterilization requirements were met. Unsterilized devices could malfunction and delay patient treatment.
Chef's Line US Foods 3 Grain Slider buns are being recalled due to foreign material (a bolt) found in the product. Approximately 8,107 cases were distributed to IL, MD, NJ, PA, and DE.
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer (206 units) because an encoder wheel misalignment on the motor shaft can cause the instrument to stop and delay patient test results.
American Contract Systems unable to confirm sterilization of 956 General Angio Pack kits distributed nationwide. Unsterile devices may lose functionality and delay patient treatment.
Medline is recalling 880 medical convenience kits containing plastic syringes with potential leaks and breakage. The syringes were identified as defective and may pose health risks to patients.