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.
Minimum severity
Erbe Medical is recalling ERBEFLO 2 Endoscopy Pump Tubing/Cap Sets due to a connector design that may allow unintended water flow, potentially leading to water aspiration and serious respiratory conditions.
AVID Medical is recalling the Halyard CATH LAB kit (Model SACL75-01) due to risk that a Medline syringe rotating adaptor may unwind during use, causing loose or complete disconnection between the syringe and manifold.
Medline Industries is recalling approximately 29,192 labor and delivery kits and OB packs due to calibration issues in sterilization equipment that may impact sterility assurance. The products were exposed to validated sterilization cycles, but the calibration problems potentially compromise sterile status.
The Halyard PERC TRAY kit (models SLPC34-01 and SLPC34-02) is being recalled due to risk that a Medline syringe rotating adaptor may unwind during use, causing a loose or full disconnection between the syringe and manifold.
AVID Medical is recalling the Halyard HEART CATH SELF REGIONAL kit (Model SELF131-05) because the Medline syringe rotating adaptor may unwind during use, causing a loose or full disconnection between the syringe and manifold.
Erbe Medical is recalling ERBEFLO CleverCap CO2 hybrid tubing and cap sets used with endoscopes because the distal connector may allow unintended water flow, potentially leading to water aspiration and serious respiratory complications.
AVID Medical recalls Halyard Cardiac Cath Pack kits (Models EAMC1000-05, WAFB208-02) due to risk that a Medline syringe rotating adapter may unwind during use, causing loose or full disconnection between the syringe and manifold.
Intuitive Surgical is recalling Intuitive 8 mm SureForm 30 Gray Reloads (Reference Numbers 48230M-05 and 48230M-06) because they may produce an incomplete staple line during curved-tipped stapler operations.
AVID Medical is recalling the Halyard NEURO IR PERIPHERAL (PS 64405) kit because the Medline syringe rotating adapter may unwind during use, causing a loose or full disconnection between the syringe and manifold.
Medline Industries is recalling multiple convenience kit models due to calibration issues with equipment used to sterilize and package the devices, which could affect sterility assurance levels.
Medline Industries is recalling multiple surgical convenience kits because equipment used to sterilize and package the devices had calibration issues that may have affected sterility assurance. The devices were processed through validated sterilization cycles but the calibration problems could impact their sterility.
Halyard SAMMC ANGIOGRAPHY kits (Model SAMM066-15) are recalled because the Medline syringe rotating adapter may unwind during use, causing a loose or disconnected connection between the syringe and manifold. 2,392 kits were distributed across US states including FL, IL, MO, MS, NC, NE, and TX.
AVID Medical is recalling Halyard CARDIAC CATH TRAY SHANDS JAX kits due to a defect in the Medline syringe rotating adaptor that may unwind during use, causing a loose or full disconnection between the syringe and manifold.
Medline Industries is recalling four Convenience Kit models (892 units) nationwide because sterilization and packaging equipment calibration issues may have compromised the sterility assurance level of the devices.
Medline is recalling five models of arthroscopy convenience kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the devices.
Mint Medical is recalling Mint Lesion software versions 3.4.0 through 3.9.5 due to a risk of data loss or incorrect patient data linking when the workstation-to-server connection is interrupted during a read operation.
BioFire Diagnostics, LLC is recalling the Spotfire Respiratory/Sore Throat Panel due to false negative test results and control failures that may not accurately detect infections.
Medline Industries is recalling eight models of Convenience Kits due to calibration issues with sterilization equipment that may have affected the sterility assurance level of the devices.
Medline Industries is recalling 114,778 surgical convenience kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the products. No illnesses or injuries have been reported.
Medline Industries is recalling 26 models of medical convenience kits used in clinical settings because equipment calibration issues may have compromised sterility assurance during sterilization and packaging.
Centinel Spine is recalling Prodisc C SK U.S. cervical disc implants due to a labeling mix-up: 6mm products were labeled as 5mm and 5mm products were labeled as 6mm, creating risk of implanting the wrong size.
Boston Scientific is recalling the LUX-DX II Model M302 and M312 arrhythmia detectors because some upgraded devices are not collecting PVC Burden data or monitoring for Bradyarrhythmia and Pause, with conflicting information shown in programming screens.
Pending LLM rewrite. Source: FDA_DEVICE Z-1981-2026.
Medline Industries is recalling multiple Convenience Kit medical devices due to calibration issues in sterilization and packaging equipment that may affect sterility assurance. The devices were distributed nationwide.
Medline is recalling two models of Convenience Kits because calibration issues with sterilization and packaging equipment may have compromised the sterility assurance level of the devices.