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.
Houston Rx LLC is recalling 7 vials of Sermorelin injectable solution due to a lack of process control. The product was distributed nationwide.
Medline is recalling 30 Foot Ankle convenience kits due to a discrepancy in the shelf-life of a component.
BioFire Diagnostics is recalling specific lots of the Joint Infection Panel due to potential contamination that could cause false positive test results.
Neuronetics is recalling 179 NeuroStar Advanced Therapy Systems because the cables in the HP Coil Assembly do not meet product specifications.
Healthmark Industries is recalling 12.8 million vinyl instrument guards because their labeling does not comply with FDA regulations and steam sterilization instructions have been updated.
Howmedica Osteonics Corp. is recalling 359 Triathlon Hinge Femoral Prep Trays because reprocessing instructions may leave residual moisture after sterilization.
Medline is recalling 165 surgical convenience kits because the cannula components do not meet ISO 80369-7 dimensional requirements and may leak or break during use.
Medline Industries is recalling 3,551 CONMED AirSeal Access Port kits due to potential overpressure alerts and system venting that may delay or end procedures.
Howmedica Osteonics Corp. is recalling 605 Triathlon Universal Baseplate Finishing Trays because reprocessing instructions may leave residual moisture after sterilization.
In2bones USA, LLC is recalling 29 bone screws labeled as fully threaded but actually partially threaded due to a labeling error.
Medline Industries is recalling 3,551 convenience kits containing CONMED AirSeal Access Ports because they may produce erroneous overpressure alerts and system venting.
Radiometer Medical ApS is recalling ABL90 FLEX and ABL90 FLEX PLUS analyzers due to a risk of potentially inaccurate results requiring updated instructions for use.
Merit Medical Systems is recalling Scout MD Delivery Systems because the implantable clip may fail to deploy, preventing the reflector from functioning as intended.
Magellan Diagnostics is recalling 321 LeadCare II Blood Lead Test Kits due to a potential expiration date labeling error that may delay test results.
Berlin Seeds is recalling alfalfa sprouting seeds due to potential E. coli and/or Salmonella contamination. The product was sold in Ohio and nationwide online.
Carolina Infusion, LLC is recalling Tirzepatide/Cyanocobalamin 26/2 mg/mL injectable syringes due to a lack of assurance of sterility related to formulation and processing equipment.
LEASA Living Alfalfa Sprouts are being recalled because the seeds may have been contaminated with E. coli. The product was distributed in Florida and New Hampshire.
K.C. Pharmaceuticals is recalling 163,008 cartons of Leader Ultra Lubricating Eye Drops due to a lack of assurance of sterility. The product was distributed nationwide under multiple brand names.
Carolina Infusion, LLC is recalling Tri-MIX injectable syringes because processing equipment used may have compromised the product's sterility.
Carolina Infusion, LLC is recalling semaglutide/cyanocobalamin injectable products due to a lack of assurance of sterility related to formulation and processing equipment.
Carolina Infusion, LLC is recalling Tirzepatide/Cyanocobalamin 85/2 mg/mL injectable syringes due to a lack of assurance of sterility related to formulation and processing equipment.
K.C. Pharmaceuticals is recalling 1,327,248 cartons of dry eye relief eye drops due to a lack of assurance of sterility. The products were distributed nationwide under multiple brand names.
Steris is recalling VERIFY Biological/Integrator Challenge Packs because the spore population may be too low, potentially causing false results in steam sterilization monitoring.
Apothecary Pharma LLC is recalling 22 vials of Tirzepatide Injection due to a lack of assurance of sterility. The affected product was distributed nationwide.
K.C. Pharmaceuticals is recalling Good Sense Eye Drops Irritation Relief and related brands due to a lack of assurance of sterility.