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 Titanium Hexed Uniscrew Dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Implant Twist Lock TM Coping Dental implants because pouches may not have been sealed during packing.
LeMaitre Vascular is recalling 1,992 units of the 1.5 mm HYDRO LeMaitre Valvulotome because the wire may detach at the handle, rendering the device inoperable.
Biomet 3i is recalling 1.6 million Straight Healing Abutment dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Preformance 15 degrees pre-angled post dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Standard Abutment Pick-Up Coping Dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling Gingihue 15 Degree Pre-Angled Post Dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling specific dental implant abutments because the packaging 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 specific O-Ring Abutments for dental implants because pouches may not have been sealed during packing.
Merge Healthcare is recalling iConnect Access software because it may display incorrect patient demographics after edits, potentially affecting medical specialists.
Biomet 3i, LLC is recalling Temporary Hexed Cylinder Dental implants because pouches may not have been sealed during packing.
Medtronic is recalling 332 Valleylab Laparoscopic Flat L-Hook Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.
Biomet 3i, LLC is recalling specific Gingihue Post dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling Locator Replacement Housing Kits because pouches may not have been sealed during packing. The recall affects 1,648,273 units distributed worldwide.
Biomet 3i is recalling Implant EP Pick-Up Coping dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling IOL Distal Extension dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling 1,648,273 Conical Healing Caps for dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling Twist Lock Straight Transfer Coping Dental Implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Prep-Tite Post Dental implants because pouches may not have been sealed during packing.
Merge Healthcare is recalling iConnect Access software because it may display incorrect patient demographics for studies originating on Merge PACS or Ortho PACS.
Biomet 3i, LLC is recalling 1,648,273 Conical 25 degree Angled Abutment Dental Implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Conical Abutment Gold Standard ZR Dental implants because pouches may not have been sealed during packing.
Biomet 3i is recalling DAL-RO Threaded Female Dental implants because pouches may not have been sealed during packing.
Biomet 3i, LLC is recalling Conical 17 degree Angled Abutment dental implants because pouches may not have been sealed during packing.
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