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.
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.
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.
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.
Mylan Pharmaceuticals is recalling specific lots of Prasugrel 5 mg tablets due to failed dissolution specifications. The affected tablets may not dissolve properly in the body.
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.
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.
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.
American Contract Systems Inc recalls 690 laceration tray kits due to inability to confirm sterilization requirements were met. The trays may lack functionality and delay patient treatment.
Immuno-Mycologics' Candida ID Antigen may have reduced sensitivity, causing false negative diagnostic results. Lot F4171005 has been distributed worldwide including CA and OK.
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.
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.
Microstream CO2 sampling lines and airway adapters may be difficult or impossible to disconnect from endotracheal tubes during clinical procedures, potentially causing treatment delays and unintended extubation with risk of serious complications.
American Contract Systems unable to confirm sterilization of 956 General Angio Pack kits distributed nationwide. Unsterile devices may lose functionality 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.
HOT ONES brand VERDE hot sauce by Heatonist is being recalled due to possible plastic foreign object contamination. Multiple sizes were distributed in North Carolina, Ohio, Indiana, and Illinois.
Microstream CO2 sampling lines and airway adapters may be difficult or impossible to disconnect from endotracheal tubes, potentially delaying treatment or causing unintended extubation. The defect affects neonatal and pediatric patients worldwide.
American Contract Systems Inc is recalling 51 kits of the EAR PACK Model SFEA12A because the manufacturer could not confirm sterilization requirements were met, which could cause device malfunction and delayed treatment.
Medline Industries is recalling Proxima Drape surgical drapes nationwide due to a potential breach in pouch packaging that could lead to loss of sterility. The recall affects 1,118 units distributed in the US.
Medline Industries is recalling 114 units of Proxima Drape surgical drapes due to a potential breach in pouch packaging that could compromise sterility. Affected units were distributed nationwide.
American Contract Systems Inc recalls 41 URO Robotic Pack surgical kits distributed in Ohio because sterilization assurance requirements could not be confirmed. Non-sterile equipment may lead to delayed treatment.
Amgen is recalling Neupogen (filgrastim) injectable vials due to stability concerns. Stability data indicates the product may be out of specification at its expiration date.
American Contract Systems is recalling 725 Labor & Delivery Packs because the manufacturer cannot confirm sterilization requirements were met. Devices may lack functionality and could delay or prolong patient treatment.
Microstream Advance neonatal-infant CO2 sampling lines may be difficult to disconnect from endotracheal tubes, potentially delaying critical procedures. This could cause unintended extubation and respiratory complications in infants.
Chef's Line 3 Grain Burgers have been recalled due to a bolt found in the product. The affected cases were distributed to Illinois, Maryland, New Jersey, Pennsylvania, and Delaware.