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.
Tornier Inc. is recalling 38 Stryker Tornier Perform Humeral System Reversed Inserts (model REF DWP2393) due to inverted locking rings. The defect may prevent the insert from seating securely in the implant stem or spacer.
The BD FACSDuet sample preparation system may dispense specimen volumes that are 3% to 20% higher in one tube versus another, leading to inaccurate blood counts, delayed test results, and potential additional blood collection. The defect affects 130 systems distributed across the US and internationally.
Big Bottom Milk Company is recalling chocolate milk because required pasteurization temperatures were not achieved. Consumers should not consume this product.
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.
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.
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 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.
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 CARDIOSAVE Rescue IABP devices have a software defect that risks hemodynamic instability and clinical data transmission failure. A software correction is available.
M&P Food Products Cheese Blintzes are recalled due to undeclared wheat in the product. Consumers with wheat allergies should not consume this frozen food.
American Contract Systems is recalling Cath Lab Pack CECL02P medical kits because an inoperable chart recorder caused humidity readings to be out-of-specification, preventing confirmation that sterilization requirements were met.
M&P Food Productions is recalling Potato & Onion Vareniki due to undeclared wheat. Consumers with wheat allergies or celiac disease should not consume this product.
American Contract Systems recalls 360 units of Endovascular AAA Pack due to inability to confirm sterilization requirements were met. An inoperable chart recorder prevented verification that environmental conditions during sterilization met required specifications.
American Contract Systems recalls the Neuro Vascular ANKV91A medical convenience kit due to inability to confirm sterilization. Affected units were distributed across MO, MN, MA, OH, and NE.
Boston Scientific recalls Wallflex FC and Agile Esophageal Stent Systems due to the potential for delivery catheter tip detachment during use. Approximately 145 units are affected worldwide.
Centinel Spine is recalling the Prodisc C SK cervical disc implant due to blue discoloration identified as foreign contamination on the inlay during assembly. The contamination was not fully evaluated in manufacturing validations.
Karl Storz Hopkins Telescope 6 endoscopes are being recalled because the instructions for use contain reprocessing procedures not reviewed or approved by the FDA. Affected units should not be used until corrected instructions are provided.
M & P Food Productions is recalling Sour Cherry Vareniki frozen dumplings due to undeclared wheat, a major allergen not listed on the label.
Boston Scientific has recalled AGILE and WallFlex esophageal stent systems due to potential delivery catheter tip detachment. This defect could occur during stent deployment and affect proper stent placement.
Cook Biotech is recalling Biodesign Fistula Plug C-FPS-0.2-2 implants because affected units expire before their labeled expiration dates. The defect could compromise product performance.
Argon Medical Devices recalls BioPince Ultra and Tru-Core II biopsy instruments due to holes in packaging trays compromising the sterile barrier, which may allow microorganism introduction and infection risk.
Assembly screws in Philips Ingenia Ambition S MRI systems may loosen and protrude, potentially blocking the patient tabletop and delaying diagnosis. Philips is recalling 64 affected units worldwide.