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 certain Gingihue 15 degree Pre-Angled Post Dental implants because pouches may not have been sealed during packing.
Stryker is recalling AutoPlex System kits because the piston head may separate, blocking the valve and causing cement backflow toward the injector handle.
Biomet 3i, LLC is recalling Locator Replacement Males dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Preformance Post Dental implants because pouches may not have been sealed during packing.
Medtronic is recalling Valleylab Laparoscopic Flexible Argon Blade Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.
MicroPort Orthopedics is recalling 14 units of Profemur Modular Necks due to a labeling error where item numbers were incorrectly assigned.
Biomet 3i, LLC is recalling specific Gingihue Post dental implants because pouches may not have been sealed during packing.
Medtronic is recalling 6,720 Valleylab Laparoscopic Straight Spatula Electrodes because the package may be compromised, potentially breaching the sterile barrier.
Biomet 3i is recalling Locator Light Retention Replacement Males because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Prep-tite Cap Dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling Pick-Up Impression Coping dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling certain Pick-Up Coping dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Preformance Temporary Cylinder Dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Standard Abutment Transfer Coping Dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling 1,648,273 dental implant devices because pouches may not have been sealed during packing.
Biomet 3i is recalling Locator Abutment dental implants because pouches may not have been sealed during packing.
Teleflex Medical is recalling 45 units of the Weck EFx Classic Fascial Closure System because incorrect expiration dates were printed on the labels.
Biomet 3i is recalling Conical EP Pick-Up Coping dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling EP Twist Lock Coping Dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling certain Bellatek Encode Healing Abutment dental implants because pouches may not have been sealed during packing.
Ortho-Clinical Diagnostics is recalling VITROS TSH Reagent Packs because calibration curves frequently fall outside quality parameters, potentially delaying test results.
Biomet 3i is recalling certain Gingihue Post Dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Locator Abutment dental implants because pouches may not have been sealed during packing.
Integra LifeSciences Corp. is recalling Universal Wire Fixation Bolts because the Slotted Post broke during use at the surgical site.
Invacare Corporation is recalling 1,011 Bariatric home care beds because the junction boxes may spark, posing a fire hazard in the presence of flammable materials.
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