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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.
Windstone Medical Packaging is recalling 51 Anterior Cervical Fusion Packs because the disposable gloves included in the kits may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 36 General Laparoscopy Packs because the disposable gloves included may have 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.
Windstone Medical Packaging is recalling 55 kits of Plastic General Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 810 Extremity Packs because the disposable gloves inside may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 66 C-Tray Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in Aligned Medical Solutions kits are recalled because splits or holes may compromise sterility.
Windstone Medical Packaging is recalling 198 Lower Extremity Packs because the disposable gloves inside 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 88 surgical packs because the gloves inside may have splits or holes that 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 60 Augmentation Packs because the disposable gloves may contain splits or holes that compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in Aligned Medical Solutions kits are 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 Aligned Medical Solutions kits are recalled because splits or holes may compromise sterility.
Cook Inc. is recalling 29 Check-Flo Introducer Hausdorf-Lock Atrial devices worldwide due to increased reports of blood loss associated with the hemostatic valve design.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in Aligned Medical Solutions kits are recalled because splits or holes may compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom Aligned Medical Solutions kits are being recalled because splits or holes may compromise sterility.
Windstone Medical Packaging is recalling 1,436 breast augmentation kits because the disposable gloves included may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom kits because splits or holes may compromise sterility.
Windstone Medical Packaging is recalling 120 Plastic Surgery Packs because the disposable gloves included may have splits or holes that compromise sterility.
Cook Inc. is recalling 1,589 Check-Flo Hemostasis Assemblies because reports indicate increased blood loss associated with the device's valve design.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in Aligned Medical Solutions kits are recalled because splits or holes may compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in Aligned Medical Solutions kits are recalled because splits or holes may compromise sterility.
Windstone Medical Packaging is recalling 174 Angio Pack kits because the Medtronic gloves inside may have splits or holes that compromise sterility.
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