Category
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.
Windstone Medical Packaging is recalling 840 custom kits because the included Medtronic gloves may contain splits or holes that compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom AMS kits are recalled because splits or holes may compromise sterility.
Windstone Medical Packaging is recalling Morris Lap Packs because the disposable gloves included in the kits may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 700 knee arthroscopy packs because the disposable gloves included may have splits or holes that compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom Aligned Medical Solutions kits are being recalled because they may contain splits or holes that compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom kits are being recalled because splits or holes may compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom kits are recalled because splits or holes may compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom Aligned Medical Solutions kits are recalled because splits or holes may compromise sterility.
Windstone Medical Packaging is recalling 276 Basic Setup Packs because the Medtronic gloves inside may have splits or holes that compromise sterility.
Matrix Surgical Holdings is recalling 28 mandible onlay implants due to packaging mislabeling where left-sided packaging contained right-sided devices.
MED-EL is recalling 538 SONNET Mini Battery Pack Cables because the compartment lock was not firmly welded to the housing.
Siemens is recalling specific Calibrator A kits due to confirmed negative bias and potential calibration failures for the FT4 assay on certain ADVIA Centaur systems.
McKesson Medical Imaging is recalling McKesson Radiology 12.2 PACS software due to a defect that may cause missing images or stuck imports.
Becton Dickinson is recalling specific lots of the BD AffirM VPIII Microbial Identification Test because blue speckles or fibers may cause invalid test results.
Siemens recalls ADVIA Centaur Calibrator A kits due to negative bias in FT4 assays and potential calibration failures on specific systems.
Biomet U.K., Ltd. is recalling Oxford Partial Knee System trial trays due to potential alumina inclusions that could cause cracking and separation.
Biomet U.K. is recalling Oxford Partial Knee instruments due to potential alumina inclusions that could cause cracking and separation.
Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.
Terumo is recalling Sarns Centrifugal Pumps because cracks in the housing can cause fluid leaks during cardiac procedures. No patient injuries have been reported.
Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.
Biomet is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.
Tosoh Bioscience is recalling 682 HLC-723G8 analyzers because they may report inaccurate HbA1c values for patients with specific hemoglobin variants.
Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.
Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.
Arrow International Inc is recalling 215,703 vascular catheter introduction kits nationwide because complaints were received regarding peel away sheaths flaring.
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