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.
Biomet 3i, LLC is recalling 1,648,273 IOL Abutment Dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling specific dental implants because their pouches may not have been sealed during packing.
Resmed is recalling 42 Quattro Air FFM masks labeled as Medium vented but containing Large non-vented masks.
Biomet 3i is recalling specific Gingihue dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling Gingihue Post Dental implants because pouches may not have been sealed during packing, potentially compromising sterility.
Biomet 3i is recalling Gold-Tite Hexed Retaining Screws because pouches may not have been sealed during packing. The recall covers 1,648,273 units distributed worldwide.
Biomet 3i is recalling Locator Extra Light Angled Replacement Males because pouches may not have been sealed during packing.
Biomet 3i is recalling 1,648,273 Flat Implant Cover Screws because pouches may not have been sealed during packing.
Biomet 3i is recalling 1,648,273 temporary dental implants because their packaging pouches may not have been sealed during packing.
Hospira is recalling Receptal canisters and liners because customers may use incorrect liner sizes, potentially causing the lid to not fit properly and reducing vacuum suction.
Biomet 3i, LLC is recalling 1,648,273 Implant EP Twist Lock Coping Dental Implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Conical Abutment Pick-up Coping Dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling 1,648,273 titanium dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling 1.6 million Bellatek Encode Healing Abutments because pouches may not have been sealed during packing.
Biomet 3i is recalling specific Gingihue dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Locator Abutment Impression Coping dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling 1,648,273 dental implant cover screws because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling specific Gingihue Post dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling specific dental implant copings because pouches may not have been sealed during packing, potentially compromising sterility.
Biomet 3i is recalling IOL Transfer Impression Coping dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling 1,648,273 Titanium Square Uniscrew Dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling IOL Pick-Up Impression Coping dental implant devices because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Conical EP Pick-Up Coping dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling IOL Abutment and Screw dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling Micromini Flat Implant Cover Screws because pouches may not have been sealed during packing.
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