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 COVER LIGHT HANDLE DISPOSABLE GLOVES in custom Aligned Medical Solutions arthroscopy kits are recalled because splits or holes may compromise sterility.
Olympus is recalling URF-V2 and URF-V2R endoscopes because the insertion tube bending section may break during surgery, causing tissue trauma.
Windstone Medical Packaging is recalling 2,018 Podiatry Packs because the disposable gloves included may have splits or holes that compromise sterility.
Beckman Coulter is recalling iChemVELOCITY Urine Chemistry Systems because probe misalignment or bending can lead to delayed or incorrect patient results.
Windstone Medical Packaging is recalling 331 laparotomy packs because the disposable gloves inside may contain splits or holes that compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom kits are recalled because splits or holes may compromise sterility.
Windstone Medical Packaging is recalling 156 Knee Scope Packs because the disposable gloves included may have splits or holes that compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom kits are recalled because splits or holes may compromise sterility.
Windstone Medical Packaging is recalling 84 Ortho Pack kits because the included Medtronic gloves may have splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 390 ENT Packs 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.
Cook Inc. is recalling 854 Check-Flo Performer Introducer Sets because a specific valve design is associated with increased reports of blood loss.
Windstone Medical Packaging is recalling 1,125 Open Procedure 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 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 360 Vascular Packs because the disposable gloves inside may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 136 D & C Kits because the disposable gloves included may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling Robotic 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.
Windstone Medical Packaging recalled 35 liposuction kits 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 Opgrande Hand Packs containing Medtronic gloves due to potential splits or holes that may compromise sterility.
Windstone Medical Packaging is recalling 875 Shoulder Pack kits because the included Medtronic gloves may contain splits or holes that compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in AMS kits are recalled because splits or holes may compromise sterility.
Siemens is recalling specific Calibrator A Kits due to a negative bias in FT4 assays and potential calibration failures on certain systems.
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