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.
Changchun Wancheng Bio-Electron's male fertility sperm test was distributed without required FDA clearance. The device may produce false diagnostic results when used at home.
Biomerieux is recalling VITEK 2 Gram-negative Susceptibility Cards due to potential quality control failures and false antibiotic resistance results. The cards are used in clinical laboratories for antibiotic susceptibility testing.
The FDA is recalling Vivoo Vaginal pH Test kits distributed without FDA clearance. The tests may produce false or inaccurate results, potentially leading to inappropriate medical decisions.
Changchun Wancheng Bio-Electron's Exploro male fertility test was distributed without required FDA clearance and may produce false or inaccurate results, potentially leading to inappropriate medical decisions.
Olympus recalls 1,490 Disposable Triple Lumen Sphincterotomes due to a manufacturing defect where improper thermoforming could cause the devices to deform and lose performance during surgical use.
Fujirebio Diagnostics is recalling Lumipulse G pTau 217 Plasma Calibrators due to inaccurate test results that could incorrectly classify patients as having or not having Alzheimer's amyloid pathology.
Olympus recalls Disposable Triple Lumen Sphincterotome Model KD-401Q-0720 devices due to manufacturing defects that could cause device deformation and loss of performance during medical procedures.
Olympus is recalling 887 units of the Disposable Triple Lumen Sphincterotome due to a manufacturing defect. Devices that did not undergo thermoforming could deform and lose performance during use.
Olympus recalls single-use sphincterotomes that may deform and lose performance if not properly thermoformed during manufacturing. No injuries have been reported.
Focalyx Fusion prostate imaging devices may not work properly on Windows 10, risking patient harm during biopsy or treatment delays. The manufacturer recommends stopping use until Windows 11 compatibility is verified.
VANTIVE US HEALTHCARE LLC recalls PRISMAFLEX ST100 dialyzer sets nationwide due to potential dislodgement of the deaeration chamber from the control unit.
Olympus is recalling approximately 11,779 Single Use 3-Lumen Sphincterotome V surgical instruments distributed in the US. Some devices may not have undergone proper thermoforming, which could cause them to deform and lose performance during use.
Vivoo Protein Test strips were distributed without FDA clearance. The unapproved devices may produce false or inaccurate diagnostic results, potentially leading to inappropriate medical treatment.
Electromagnetic contactors in FDR Visionary Suite X-ray generator cabinets may stay powered after shutdown, risking overheating and fire. 16 units affected in eight US states.
Olympus Corporation is recalling 10,257 units of Single Use 3-Lumen Sphincterotome V endoscopic instruments. Some devices did not undergo thermoforming during manufacturing and could deform and lose performance.
Olympus Corporation is recalling the Single Use 3-Lumen Sphincterotome V surgical device due to a manufacturing defect where some devices may not have undergone proper thermoforming, potentially causing deformation and performance loss during surgical procedures.
Vantive US Healthcare is recalling the Prismaflex HF1000 SET dialyzer due to a potential dislodgement of the deaeration chamber from the control unit. The recall affects 93,576 units distributed nationwide.
Encore Medical recalled EMPOWR 3D Knee Tibial Insert devices and other orthopedic implants due to packaging discrepancies that may deliver wrong devices, potentially requiring surgical delay or revision procedures.
Multiple brands of UTI test strips have been recalled for distribution before FDA clearance. The strips may produce false or inaccurate results that could lead to inappropriate medical decisions.
Siemens is removing three software applications from SOMATOM X.ceed CT systems worldwide because they lack FDA 510(k) clearance. Affected units are being recalled to ensure regulatory compliance.
Olympus Corporation is recalling the KD-640L electrosurgical knife nationwide due to deterioration causing overheating, burning, and tip breakage risk during surgery.
Diagnostic test strips for S. Typhi and Para Typhi A antigens were distributed without FDA approval and may provide inaccurate results, potentially leading to inappropriate medical intervention.
VANTIVE US Healthcare is recalling 264,040 PRISMAFLEX ST150 dialyzers nationwide due to potential dislodgement of the deaeration chamber from the control unit during use.
Olympus is recalling its KD-645 electrosurgical knife due to deterioration of the cutting knife that can cause overheating, burning, and tip breakage during endoscopic surgery. A total of 3,361 units have been distributed nationwide.
Fujirebio Diagnostics is recalling the Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio diagnostic test because it may produce falsely elevated positive or indeterminate results, causing patients to be incorrectly classified as having Alzheimer's disease or requiring unnecessary further testing.