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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 ADVANTA VXT vascular grafts due to separation of the slider mechanism. The defect affects over 53,000 units distributed worldwide and could compromise graft 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 Corporation is recalling ADVANTA VXT vascular grafts after reports of separation between the Slider GDS Swivel Rod and Swivel Core. This structural defect could affect device performance.
Atrium Medical is recalling ADVANTA VXT vascular grafts due to complaints of separation between the slider rod and swivel core, which could affect proper device function.
FDA recalls Atrium Medical's FLIXENE vascular grafts due to reports of the swivel rod separating from the core, potentially compromising device integrity.
A defective drip chamber in the Alaris Pump Infusion Set may detach from the tubing, potentially delaying treatment or causing unintended exposure to medications. BD is recalling approximately 11,300 units distributed across the US and Canada.
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.
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.
GE HealthCare CRITIKON ONE-CUF blood pressure cuffs may provide inaccurate measurements. The FDA recalls approximately 23,180 boxes distributed across 20 US states.
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.
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reports of the swivel rod separating from the swivel core. Patients and healthcare providers should contact the manufacturer for guidance.
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.
ADVANTA VXT vascular grafts may experience separation of the slider component from its core. This Class II recall affects 53,308 units distributed worldwide.
ADVANTA VXT vascular grafts are being recalled because the Slider GDS Swivel Rod may separate from the Swivel Core. This affects about 53,308 units distributed worldwide including the US.
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 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 recalled 53,308 ADVANTA VXT vascular grafts worldwide due to reported separation of the swivel rod from the swivel core. The affected units were distributed throughout the United States and to 60 additional countries.
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.
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 is recalling ADVANTA VXT vascular grafts due to reports of the slider rod separating from the swivel core, which could impair proper device function.
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. No injuries have been reported.
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 is recalling 53,308 ADVANTA VXT vascular grafts worldwide due to reported separation of the slider rod from the swivel core, with a gap observed between the components.
Atrium Medical is recalling 53,308 ADVANTA VXT vascular grafts due to reports of Slider GDS Swivel Rod separation from the Swivel Core. Component separation could compromise device function.
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.
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