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.
ConMed Linvatec is recalling PressFT HI-FI Sutures because the driver tip may separate from the shaft after implant insertion.
ConMed Linvatec is recalling PressFT HI-FI Sutures because the distal tip of the driver may separate from the shaft after the implant is inserted.
Osteotech Inc is recalling multiple lots of Grafton and Xpanse bone graft products because the sterility of the inner pouch surface may be compromised.
ConMed Linvatec is recalling Press FT HI-FI Sutures because the driver tip may separate from the shaft after implant insertion.
Teleflex Medical is recalling 126 units of Hem-o-lok Large Polymer Ligating Clips because pinholes in the trays may compromise sterility.
Osteotech is recalling multiple lots of Grafton and Xpansé bone graft products because the sterility of the inner pouch surface may be compromised.
Osteotech is recalling multiple lots of Grafton and Xpanse bone graft products because the sterility of the inner pouch surface may be compromised.
The Anspach Effort, Inc. is recalling 16 Electric Systems Foot Controls because the foot control cable lacks a shield connection. The defect could affect the device's performance during surgical procedures.
ConMed Linvatec is recalling PressFT HI-FI Sutures because the driver tip may separate from the shaft after the implant is inserted.
Osteotech Inc is recalling multiple lots of Grafton and Xpanse bone graft products because the sterility of the inner pouch surface may be compromised.
Osteotech is recalling multiple lots of Grafton and Xpanse bone graft products because the sterility of the inner pouch surface may be compromised.
Osteotech is recalling multiple lots of Grafton and Xpans bone graft products because the sterility of the inner pouch surface may be compromised.
MOOG Medical Devices Group is recalling 12,000 Curlin Infusion Administration Sets due to an incomplete previous recall regarding unclearable Air-In-Line alarms.
Belmont Instrument Corporation is recalling 2,913 Rapid Infuser units because saline leakage caused an electrical flash at the power entry area.
Osteotech Inc is recalling multiple lots of Grafton and Xpanse bone graft products because the sterility of the inner pouch surface may be compromised.
Beckman Coulter is recalling AutoMate 1250 and 2550 systems due to a risk of sample misidentification caused by duplicate barcode labels.
Osteotech Inc is recalling multiple lots of Grafton and Xpanse bone graft products because the sterility of the inner pouch surface may be compromised.
Osteotech Inc is recalling multiple lots of Grafton and Xpanse bone graft products because the sterility of the inner pouch surface may be compromised.
Trumpf Medical Systems is recalling 275 Helion and Xenion surgical lights due to reported fractures of the front joint of the spring arm.
Boston Scientific is recalling 19,716 Leveen Coaccess Introducer Sets because the Portuguese instructions for use contain errors. The devices were distributed in Brazil, Portugal, and Hong Kong.
Zimmer Inc. is removing CPT Modular Hip Stems from the market because they were packaged in incorrect cartons and distributed internationally and domestically.
Zimmer Inc. is removing CPT hip stems from the market because they were packaged in incorrect cartons and distributed domestically and internationally.
Boston Scientific is recalling Leveen Coaccess Needle Electrodes because the Portuguese instructions for use contain errors. The recall affects units distributed in Brazil, Portugal, and Hong Kong.
Beckman Coulter is recalling 18 Unicel Closed Tube Aliquotter units because a hardware motion error may occur. The recall covers units distributed in the US and several international locations.
Terumo is recalling 33 Backplate Replacement CXFVR 1500 Holders because they were manufactured with an incorrect configuration of connector supports.
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