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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.
Atrium Medical's ADVANTA VXT vascular grafts are being recalled worldwide due to reports of the Slider GDS Swivel Rod separating from the Swivel Core. The separation creates a gap that could compromise device function.
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts because the Slider GDS Swivel Rod may separate from the Swivel Core. A total of 53,308 units are affected.
CORENTEC's LOSPA Patella Component knee implants are recalled due to an unsupported 10-year expiration date. Thirty-five units were distributed nationwide.
Atrium Medical Corporation recalled 53,308 ADVANTA VXT vascular grafts worldwide due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. Patients should consult their healthcare provider regarding appropriate follow-up care.
Atrium Medical Corporation is recalling FLIXENE vascular grafts due to reported separation of the swivel rod from the core component. This defect could compromise device function.
Atrium Medical is recalling FLIXENE vascular grafts due to complaints of separation between the Swivel Rod and Swivel Core components. The recall affects 53,308 units worldwide, including 11,236 in the US.
Atrium Medical is recalling ADVANTA VXT vascular grafts due to reports of the slider GDS swivel rod separating from the swivel core. Approximately 53,308 units are affected worldwide.
Atrium Medical recalls FLIXENE vascular grafts due to reported separation of the Swivel Rod from the Swivel Core, creating gaps that could affect device function. Over 53,000 units worldwide are affected.
Atrium Medical Corporation recalls Advanta VXT vascular grafts due to separation of internal swivel components. Approximately 53,308 units worldwide are affected, with the slider GDS swivel rod potentially separating from its core.
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. Approximately 53,308 units have been affected worldwide.
Atrium Medical recalls FLIXENE vascular grafts due to complaints of the Slider GDS Swivel Rod separating from the Swivel Core. Component separation in implanted vascular grafts could compromise device function.
Atrium Medical's ADVANTA VXT vascular graft may experience separation of the slider mechanism from its core, affecting over 11,000 US units. No injuries have been reported.
Atrium Medical is recalling ADVANTA VXT vascular grafts worldwide after reports of the slider swivel rod separating from the swivel core with a notable gap between components.
Newport has recalled Class II laser systems because their key-actuated safety switch can be removed while the laser remains on, violating federal safety requirements.
Atrium Medical is recalling ADVANTA VXT vascular grafts worldwide due to complaints of the swivel rod separating from the core, which could compromise device function during medical procedures.
Atrium Medical Corporation is recalling FLIXENE vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. The recall affects 53,308 units distributed worldwide.
ADVANTA VXT vascular grafts may have separation of the Slider GDS Swivel Rod from the Swivel Core. Atrium is recalling affected units.
Verathon is recalling GlideScope Core 15-inch monitors due to software issues causing potential image loss or degradation. Approximately 2,568 units were distributed across the US and internationally.
The Arial mobile application experiences frequent restarts on iOS 17.4 and 17.5, causing alert overload, communication failures, and offline status in healthcare facilities.
Atrium Medical Corporation is recalling approximately 53,308 FLIXENE vascular graft units worldwide due to reported separation of the Slider GDS Swivel Rod from the Swivel Core, creating gaps that could affect device performance.
Medline Industries is recalling over 5 million Luer Slip disposable syringes because testing documentation does not confirm they deliver accurate volumes across their claimed capacity range. This poses a risk to patient health.
Atrium Medical is recalling ADVANTA VXT vascular grafts due to reports of separation between the Slider GDS Swivel Rod and Swivel Core, potentially affecting device functionality.
Medline Industries is recalling over 2.3 million syringes due to identified leaks, breakage, and quality issues that may pose risks to patient health. The affected syringes were distributed nationwide and internationally.
Atrium Medical recalls ADVANTA VXT vascular grafts due to reports of the Slider GDS Swivel Rod separating from the Swivel Core. The internal component separation could compromise device function.
Atrium Medical Corporation is recalling its ADVANTA VXT vascular graft due to reports that the Slider GDS Swivel Rod can separate from the Swivel Core, creating a gap between components.
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