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FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Medical device recalls are the FDA's highest-volume stream. They cover implantable devices like pacemakers and joint replacements, hospital diagnostics and lab analyzers, surgical instruments, software-as-a-medical-device, and consumer-facing hardware like CPAP machines, blood-pressure cuffs, and glucose monitors. The volume comes from the wide range of products in scope and from the FDA's broad definition of 'corrective action' — software updates, IFU revisions, and labeling corrections all show up as recalls.
For Class I device recalls, the device's defect creates a reasonable risk of serious injury or death — these are the urgent ones. Class II covers issues that may cause temporary or medically reversible harm, often around accuracy or calibration. Class III is for products that don't comply with FDA rules but pose no real safety risk; in practice many software-update letters are Class III.
If you depend on a recalled device for ongoing care, don't disconnect or stop using it before talking to the prescribing clinician — interrupting therapy for a CPAP or a continuous glucose monitor can be more dangerous than the recall it's responding to. Almost every device recall offers a remedy that doesn't require you to surrender the device first.
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 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 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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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 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.
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.
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.
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 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 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.
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 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.
DFI Co., Ltd. is recalling the One Step pH in vitro diagnostic test because it was distributed without required FDA premarket clearance or approval.
Medline is recalling Convenience Kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the products.
Katalyst Surgical is recalling DEX Ophthalmic Tissue Forceps, 25ga Model DVF4016-25-S due to a field safety corrective action for instructions for use (IFU). The recall affects 90 units distributed nationwide in the US and internationally.
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