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FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
BioFire Diagnostics is recalling its Joint Infection (JI) Panel diagnostic test kits due to contamination that may produce false positive results.
Medline Industries is recalling approximately 15,806 surgical device kits used in gynecology, urology, and thoracic procedures. Calibration issues with sterilization and packaging equipment may have compromised the sterility assurance level of the devices.
Centinel Spine is recalling Prodisc C SK U.S. Implant Extra Large cervical disc replacement devices due to a labeling mix-up where 6mm implants were labeled as 5mm and 5mm implants were labeled as 6mm.
Erbe Medical is recalling ERBEFLO CleverCap hybrid tubing and cap sets for endoscopes due to a connector configuration that may allow unintended water flow, potentially leading to water aspiration and serious respiratory complications.
Medline Industries is recalling Convenience Kits (Model DYKMBNDL200A) due to calibration issues in sterilization equipment that may have compromised sterility assurance. The kits were distributed nationwide.
Medline Industries is recalling Triple Lumen Insertion Kits (Model DYNDM1031A) due to calibration issues with sterilization equipment that may have compromised the sterility assurance level of the products.
Medline Industries is recalling over 7,700 surgical convenience kits due to calibration issues with sterilization and packaging equipment that may affect the sterility assurance level of the products.
Medline is recalling certain Dental Pack and Surgical Pack convenience kits due to calibration issues with sterilization equipment that may affect sterility assurance. Approximately 3,508 units were distributed nationwide.
Physio-Control defibrillators (LIFEPAK 15, 1000, 35, and 20e models) serviced between July 2023 and November 2025 may not have undergone required Performance Inspection Procedures, potentially preventing therapy delivery.
Medline is recalling 52 models of neurosurgical convenience kits due to calibration issues with sterilization equipment that may have compromised the sterility assurance level of the products.
Medline Industries is recalling multiple Convenience Kits nationwide because sterilization equipment calibration issues may have compromised the sterility assurance level of the products, despite exposure to validated sterilization cycles.
Medline is recalling Basic Nerve Block Trays due to calibration issues with sterilization equipment that may have compromised the sterility assurance level of the devices.
Medline Industries is recalling multiple Convenience Kit models used in cardiac, vascular, and surgical procedures due to calibration issues with sterilization and packaging equipment that could impact sterility assurance. Approximately 39,341 units distributed worldwide may be affected.
Medline Industries is recalling two models of Convenience Kits because calibration problems with sterilization and packaging equipment may have compromised the sterility of the products.
Medline is recalling Convenience Kits (PPE Kit, Model DYK1011945P) due to calibration issues with sterilization and packaging equipment that may compromise sterility assurance. The product was distributed nationwide.
Medline is recalling Convenience Kits (Model DYNJ50806L) because equipment calibration issues may have affected the sterility assurance level of the devices. The products were exposed to sterilization and packaging cycles but the calibration problems could impact their sterility.
Boston Scientific's LUX-Dx II Plus implantable cardiac monitors may fail to collect PVC Burden data or monitor for abnormal heart rhythms in some upgraded devices, creating potential gaps in patient monitoring.
Medline is recalling three models of medical convenience kits (central line, LVAD driveline, and surgical oncology) distributed nationwide due to calibration issues in sterilization equipment that may have reduced sterility assurance.
Medline Industries is recalling 12,529 units of sterile surgical convenience kits used in cesarean section and obstetric procedures worldwide due to equipment calibration issues that may compromise sterilization assurance.
Medline Industries is recalling three models of medical trays due to calibration issues with sterilization equipment that may affect sterility assurance. The recall affects LVAD Driveline Trays and Central Line Dressing Change Trays distributed nationwide.
Orthorebirth Co Ltd is recalling BioCera Fibers, a bioresorbable bone void filler, because the product falls outside standard specifications. The recall affects 1266 units distributed nationwide in California and Florida.
Intuitive Surgical is recalling certain Universal Surgical Manipulator arm sub-assemblies in da Vinci X and Xi Surgical Systems due to screws that may be susceptible to breaking during use.
Medline Industries is recalling cardiac surgery convenience kits because sterilization and packaging equipment calibration issues may have affected the sterility assurance level of the devices.
Medline Industries is recalling multiple convenience kits used in surgical and biopsy procedures due to calibration issues with sterilization equipment that may affect sterility assurance. The recall affects 4,064 units distributed nationwide.
Medline is recalling multiple models of surgical drapes due to calibration issues with sterilization and packaging equipment that may have compromised the sterility assurance level of the products. All affected units were distributed nationwide.
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