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.
The Posh Bakery recalls Whole Grains Bakery Banana Nut Muffins (6 oz) due to undeclared milk and wheat allergens. The muffins lack required allergen-contains statements and nutritional fact labels.
Big Bottom Milk Company is recalling 701 units of Chocolate Milk Grade A (1-pint bottles) distributed in Georgia, North Carolina, and South Carolina due to failure to achieve required pasteurization temperatures.
Young Dental Manufacturing is recalling BIOTROL PURIT Clean-It Ultrasonic Cleaner (REF PC016) due to bacterial contamination in the bulk product used for repackaging. The recall affects 1,391 units distributed across 10 states.
Mini Raspberry Lemon Coffee Cake products in Washington were mislabeled and contain undeclared walnuts and wheat. Consumers with allergies to these ingredients should not consume the product and should return it to the store.
Blue Tape Sriracha sauce (136 bottles, 10.5 oz each) was manufactured without the required authorization for producing acidified foods, creating potential safety risks.
Healgen Scientific is recalling 1,636,994 urinalysis test strips in California, Georgia, and Texas due to reduced protein detection sensitivity that may produce false negative results and delay kidney disease diagnosis.
Grace Imports recalled Kerala Mixture snack due to undeclared wheat allergen. The supplier failed to disclose wheat on the product label, posing a risk to consumers with wheat allergies.
The Posh Bakery is recalling Cranberry Muffins due to undeclared whey (milk) and wheat flour, as well as missing nutrition facts panel and allergen statement. Consumers with milk or wheat allergies should not consume these products.
The DVOT SARS-CoV-2 Antigen Test Kit (Model FCY-AGT-01) manufactured by Feng Chun Yuan Medical Equipment has been recalled from the U.S. market because it was not authorized for sale in the United States.
The DVOT SARS-CoV-2 & Influenza A+B Antigen Combo Test Kit (Model FAT01) has not obtained FDA authorization for sale in the United States. All lots distributed in the U.S. are subject to recall.
Ryaltris nasal spray is being recalled because the dip tube is clogged, preventing the spray from functioning. The recall affects 45,504 bottles distributed nationwide.
Glenmark Pharmaceuticals is recalling Ciclopirox Gel 0.77% tubes nationwide due to broken seals. The recall affects 11,568 tubes; no illnesses or injuries have been reported.
Smiths Medical is recalling paraPAC Plus 310 ventilators because the patient outlet connector may loosen or detach, potentially interrupting ventilation. Approximately 11,244 units worldwide are affected.
Datascope Corp. is issuing a software correction for CARDIOSAVE RESCUE intra-aortic balloon pump devices to address risks of hemodynamic instability and failure to properly transmit clinical data worldwide.
Datascope's Cardiosave Hybrid IABP devices carry a risk of hemodynamic instability and clinical data transmission failure due to a software defect. Datascope has developed a software correction (Revision D.00) to mitigate this risk.
Datascope Corp. is recalling the CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP globally due to software defects risking hemodynamic instability and clinical data transmission failure.
Boston Scientific is recalling Agile Esophageal Over the Wire Stent Systems because the delivery catheter tip may detach. The recall affects 19 units distributed worldwide.
Boston Scientific is recalling Agile Esophageal Stent Systems because the delivery catheter tip may detach. The recall affects 17 units distributed worldwide.
Datascope CARDIOSAVE Rescue IABP devices have a software defect that risks hemodynamic instability and clinical data transmission failure. A software correction is available.
Fresenius Kabi is recalling Ivenix Infusion System software (Version 5.9.1 and prior) due to anomalies that can cause pump malfunctions, alarms, or unresponsive screens while delivering medication, risking serious patient harm.
Smiths Medical is recalling 3,182 paraPAC 300 ventilator kits because the patient outlet connector may loosen or detach, impacting active ventilation.
Centinel Spine is recalling the Prodisc C SK cervical disc replacement due to blue discoloration on the inlay observed during assembly. This discoloration is a foreign contaminant that was not fully evaluated in manufacturing validations.
The Ingenia Elition X MRI device may have loose screws that interfere with the horizontal tabletop, potentially delaying patient diagnosis and causing anxiety during extended bore exposure.
American Contract Systems is recalling 60 Shoulder SESH18I medical convenience kits nationwide due to equipment failure that resulted in out-of-specification humidity readings, preventing sterilization assurance confirmation.
American Contract Systems is recalling the Essentia MAJ Laparotomy Std Pack because an equipment failure prevented confirmation of sterilization requirements for this medical convenience kit.