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 Healing Abutment Dental Implants because pouches may not have been sealed during packing.
Bard Peripheral Vascular Inc is recalling 1,250 TruGuide Disposable Coaxial Biopsy Needles because some units may contain two trocar or two blunt tip stylets instead of one of each.
Biomet 3i, LLC is recalling dental implant cover screws because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Pick-up Coping Dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling headless dental implant cover screws because pouches may not have been sealed during packing.
Biomet 3i is recalling 1.6 million dental implant abutments because some pouches may not have been sealed during packing.
Ab Sciex is recalling MultiQuant MD software for 3200MD mass spectrometers because it may display incorrect quantitative results when using the Sum Multiple Ions feature.
Mindray is recalling Passport Series Patient Monitor CO2 Modules due to a potential leakage issue with the Dryline II Water Trap.
Biomet 3i, LLC is recalling IOL Healing Cap dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Standard Abutment Temporary Screws because pouches may not have been sealed during packing.
Biomet 3i is recalling Gold-Tite Hexed Retaining Screws because pouches may not have been sealed during packing.
Biomet 3i is recalling specific dental implant abutments because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling 1,648,273 dental implant cover screws because pouches may not have been sealed during packing.
Biomet 3i is recalling Locator Extended Range Males dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling 1,648,273 Pick-Up Coping dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling 1,648,273 EP Pick-Up Coping Dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling specific dental implant abutments because their packaging pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Standard Abutment Dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling O-Ring Abutments for dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling Gold Slotted Screw Dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling certain EP Healing Abutment dental implants because pouches may not have been sealed during packing.
GE Healthcare is recalling 498 Centricity PACS Workstations due to a software defect that causes random image-series grouping errors when specific exams are opened simultaneously.
Biomet 3i, LLC is recalling DAL-RO Housing, Female Assembly dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Gingihue 15 degrees Pre-Angled Post dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling Preformance 15 degrees Pre-Angled Post Dental implants because pouches may not have been sealed during packing.
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