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.
Medtronic is recalling COVER LIGHT HANDLE DISPOSABLE GLOVES because they may contain splits or holes that compromise sterility.
Windstone Medical is recalling Percutaneous Entry Kits because the included Medtronic gloves may have splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 356 Minor Arthroscopy Packs because disposable gloves in the kits may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 2,048 Dr. Landi EVLT Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.
The FDA is recalling Medtronic disposable gloves used in Lap Band kits because splits or holes may compromise sterility.
Windstone Medical Packaging is recalling 1,025 minor surgery kits because the Medtronic gloves included may have splits or holes that compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility.
Windstone Medical Packaging is recalling 249 Lumbar Laminectomy Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling Brow Pack kits because they may contain defective gloves that compromise sterility.
Windstone Medical Packaging is recalling Bayview Breast Packs because disposable gloves in the kits may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 2,266 Basic Face Kits because the Medtronic gloves included may have splits or holes that compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in surgical kits.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.
Philips is recalling 2,212 IntelliVue MX40 patient monitors worldwide because a configuration setting may disable ECG alarms. Users should contact Philips for a software update.
Windstone Medical Packaging is recalling 592 D & C Kits because disposable gloves in the kits may contain splits or holes that compromise sterility.
Medtronic is recalling disposable gloves used in custom surgical kits because they may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 30 Hall SAP surgical kits because the included Medtronic gloves may have splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 15 Abdominoplasty Packs because the included Medtronic gloves may have splits or holes that compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom surgical kits.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 272 Knee Scope Packs because the included Medtronic gloves may have splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 648 Dr Mullins surgical kits because the Medtronic gloves inside may have splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 32 Laparotomy Tray kits because the included Medtronic gloves may contain splits or holes that compromise sterility.
Medtronic is recalling COVER LIGHT HANDLE DISPOSABLE GLOVES because splits or holes may compromise sterility. The gloves are part of custom surgical kits.
Windstone Medical Packaging is recalling 58 Total Joint Packs because the disposable gloves inside may contain splits or holes that compromise sterility.
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