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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 is recalling the ADVANTA VXT vascular graft due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. This component separation could affect device function.
Atrium Medical Corporation recalled FLIXENE vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. Over 53,000 units are affected worldwide.
Atrium Medical is recalling ADVANTA VXT vascular grafts due to separation of the slider swivel rod from its core. This structural defect could lead to device failure. Over 53,000 units are affected worldwide.
Verathon recalls 1,706 GlideScope Core 15-inch FHD monitors due to a software defect in versions v1.7 and earlier. The defect can cause loss or degradation of image when the monitor is used with other connectable devices.
Stryker Neurovascular is recalling certain lots of Synchro2 Guidewires due to PTFE coating damage caused by backloading through an introducer accessory with manufacturing variations. Affected users should discontinue the backloading technique.
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.
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 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'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 recalls FLIXENE vascular graft devices due to reported separation of the Slider GDS Swivel Rod from its core, which could affect device function.
Ion Beam Applications' IBA Proton Therapy System PROTEUS 235 may continue delivering radiation when critical accelerator control parameters are outside defined tolerances. Affected users should contact the manufacturer regarding firmware updates.
Atrium Medical is recalling ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. This component separation could compromise device function.
ADVANTA VXT vascular grafts are recalled due to reported separation of the Slider GDS Swivel Rod from the Swivel Core, creating a gap between components.
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to complaints of separation of the Slider GDS Swivel Rod from the Swivel Core. Over 53,000 units have been distributed worldwide.
Atrium Medical Corporation is recalling ADVANTA VXT vascular graft devices due to reports of the swivel rod separating from the core. The separation could compromise device function.
Olympus OES 4000 Hysteroscope Model A4674A is being recalled because a required leakage test was not performed after device repairs. Liquid could enter the eyepiece, causing a foggy image during use.
Atrium Medical recalls Advanta VXT vascular grafts due to swivel rod separation from the core component. Approximately 53,308 units are affected worldwide.
Atrium Medical recalls FLIXENE vascular grafts due to reported separation between the slider rod and swivel core. Affected grafts may fail to function properly if deployed.
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 recalls ADVANTA VXT vascular grafts due to reported separation of the slider swivel rod from its core, creating a gap between components. No injuries reported.
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'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 due to reports of the slider rod separating from the swivel core, which could impair proper device function.
Ortho-Clinical Diagnostics is recalling VITROS Vitamin B12 Range Verifier Lot 1200 because the product may fail to verify required calibration range. The failure is detectable during use and does not affect actual patient test results.
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