Recalls
Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.
Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.
The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.
Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.
Minimum severity
SoClean, Inc is voluntarily recalling 40,075 units of the SoClean 3 sleep equipment cleaner due to potential ozone gas exposure. The manufacturer is providing an updated user manual with safety instructions and a protective hose and mask adapter.
Abiomed is recalling its Oscor Introducer Kit due to holes in the outer pouch that may compromise the sterile barrier. Non-sterile introducers could expose patients to infection, bacteremia, or sepsis.
Ambu is recalling the aView 2 A Monitor due to fire and burn hazards if mounting screws longer than 16mm are used. Improper installation can penetrate the lithium-ion battery, causing fires, severe burns, and smoke inhalation.
Baxter Healthcare Corporation is recalling 2,985 units of the XScribe Cardiac Stress Testing System, version 6, due to potential distortion in electrocardiogram readings when the Source Consistency Filter is enabled. No injuries have been reported.
Immunostics is recalling H. Pylori diagnostic test kits due to mislabeled expiration dates. Using the product after expiration may produce false positive, false negative, or invalid results.
Abbott ARCHITECT c4000 Processing Module laboratory analyzers are recalled due to unlabeled dry natural rubber (latex) subcomponents. Individuals with latex allergies may experience allergic reactions if exposed to the undisclosed component.
Medtronic is recalling 4,235 percutaneous surgical pins that may have a manufacturing defect preventing proper fit into or removal from the tap cap. The pins were distributed nationwide and internationally.
Abiomed introducer kits may have holes in the outer pouch, compromising sterility and exposing patients to potential microbial contamination. This could lead to serious infections including bacteremia or sepsis.
Icotec is recalling VADER pedicle system torque wrenches because the torque limiting function can malfunction, potentially leaving screw fasteners insufficiently tightened during implant surgery.
The SPRYSTEP VECTOR KAFO custom ankle-foot orthosis is being recalled by Townsend Design due to air pockets that could cause complete structural failure.
Philips is recalling BrightView Gamma Camera Systems because a gap can form between patient support and detector during quality assurance scans, creating an extremity entrapment hazard that may cause fractures or crush injuries.
Baxter Healthcare has recalled a marketing brochure for its Preveleak Surgical Sealant due to inaccurate content that does not align with the product's Instructions for Use. Healthcare providers and consumers should consult the accurate product Instructions for Use and Prescribing Information.
Boston Scientific is recalling pacemaker programmer software that displays certain diagnostic dates incorrectly, with dates showing years in the 1990s. Affected diagnostic information may impact clinical monitoring.
Philips is recalling Incisive CT scanners due to nine software defects including image artifacts, incorrect orientation labels, display failures, and positioning errors that could lead to misdiagnosis or need for rescans. No illnesses have been reported.
Baxter Healthcare is recalling marketing materials for its Vascu-Guard Peripheral Vascular Patch because a cardiovascular surgery brochure contains inaccurate content conflicting with official Instructions for Use and Prescribing Information.
Olympus Corporation is recalling 271 ENDOEYE Flex Deflectable Videoscopes due to deviations in reprocessing instructions. Proper sterilization procedures are critical for safe endoscopic use.
Medtronic is recalling NIM TriVantage EMG Endotracheal Tubes worldwide for noise, lead-off issues, high impedance, and loss of or intermittent nerve monitoring. The 80,569 affected units may fail to provide reliable nerve monitoring function.
BD Biosciences is recalling CD11b APC diagnostic reagent vials that may produce dim fluorescence signals, potentially causing false negative results and misdiagnosis of blood cancers.
Abiomed Axillary Insertion Introducer Kits have holes in the outer pouch that may compromise sterility, potentially exposing patients to serious infections including bacteremia and sepsis.
Abiomed is recalling Oscor Intro Introducer Kits due to holes in the outer pouch that may compromise the sterile barrier, potentially exposing patients to harmful bacteria and infections including bacteremia and sepsis.
BioFire FILMARRAY GI Panel diagnostic test kits may return false negative results due to a manufacturing event, potentially leading to missed diagnoses and inappropriate treatment. The affected kits were distributed to locations in 16 U.S. states.
Two Olympus ENDOEYE HD II Rigid Videoscope catalog numbers (WA50040A, WA50042A) have been recalled due to reports of pink or green image discoloration during use. The issue could require device exchange during surgery and potentially result in visual impacts or bleeding.
Townsend Design is recalling the SPRYSTEP VECTOR custom ankle-foot orthosis due to potential air pockets between material layers that could cause complete structural failure. Users should stop using the device and contact the manufacturer.
Olympus is updating instructions for the VISERA Cysto-Nephro Videoscope (Model CYF-V2) nationwide, removing reusable brushes from manual cleaning procedures. Single-use brushes remain compatible.
Abiomed is recalling introducer kits due to holes in the outer pouch that compromise the sterile barrier. Non-sterile product could allow microbial contamination, leading to infection such as bacteremia or sepsis.