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.
Integra LifeSciences is recalling 250 units of the TCC-EZ Total Contact Cast System because a quarantined lot may produce excessive heat.
Sofradim Production is recalling Versatex Monofilament Mesh due to patient reports of abdominal hernia recurrence following repair. The firm has updated instructions to warn surgeons about risks in specific procedures.
Stryker is recalling T5 Zipper Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.
Stryker is recalling T4 Pullover Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.
Stryker is recalling T5 Zipper Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.
Zimmer Biomet is recalling ZMS Intramedullary Fixation Smooth Guide Wires due to potential failure of the sterile packaging seal.
Zimmer Biomet is recalling 19,483 Natural Nail System Tear Drop Guide Wires due to a potential failure of the sterile packaging seal.
FDA is recalling EEA Hemorrhoid and Prolapse Stapler Sets due to a potential welding defect that could cause bleeding or anastomotic leak.
Zimmer Biomet is recalling 19,483 M/DN Intramedullary Fixation Humeral Guide Wires because the sterile packaging seal may fail, potentially compromising sterility.
BioFire Diagnostics is recalling the FilmArray BCID Panel because it may produce false positive Proteus results when used with specific BD BACTEC blood culture bottles.
Synthes, Inc. is recalling 31 Stem Extractor f/Guide Bar units because the connection screw may break during use.
Stryker is recalling T4 Zipper Toga sterile garments because material layers may separate, creating a risk of exposure to contaminants.
Covidien LLC is recalling EEA Hemorrhoid and Prolapse Stapler Sets because a defective staple guide may cause bleeding or anastomotic leak during surgery.
Stryker is recalling T4 Zipper Toga sterile personal protection garments because material layers may separate, creating a risk of exposure to contaminants.
Stryker is recalling T4 Zipper Toga sterile personal protection garments because material layers may separate, posing a risk of exposure to contaminants.
Zimmer Biomet is recalling ZMS Intramedullary Fixation Smooth Guide Wires due to potential failure of the sterile packaging seal.
Life Technologies is recalling 30 units of the Oncomine Dx Target Test because a lower RNA concentration could cause false negative results for ROS1 fusion, potentially affecting patient treatment.
Stryker is recalling T4 Pullover Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.
Stryker is recalling T4 Pullover Toga sterile garments because material layers may separate, creating a potential risk of exposure to contaminants.
Stryker is recalling T4 Pullover Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.
Integra LifeSciences is recalling 1,619 humeral stem trials for the Titan Modular Shoulder System because they may break during surgery.
Stryker is recalling T4 Pullover Toga sterile garments because material layers may separate, creating a risk of exposure to contaminants.
Zimmer Biomet is recalling Humeral Guide Wire Ball Tips because the sterile packaging seal may fail, potentially compromising the device's sterility.
Becton Dickinson is recalling BD Vacutainer Ultra Touch Push Button Blood Collection Sets because they do not meet the labeled sterility assurance level.
Terumo Cardiovascular Systems Corporation is recalling seven Flowmeter Modules for the Advanced Perfusion System 1 due to inaccurate flow readings that may be difficult to detect.
Looking for a different category? Browse all recalls.