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.
Burlington Medical is recalling thyroid shields over the potential for attenuation degradation over time, which decreases the product's usable lifespan. 41,962 units are affected.
Mentor Texas is recalling Artoura Breast Tissue Expanders because the infusion sets may contain a dull or blunt needle tip that may be difficult to advance or may break.
Olympus is recalling SOLTIVE Pro SuperPulsed Laser Systems because a potential defect in the 24V power supply module may render the system inoperable and produce smoke or a burning smell.
Intuitive Surgical is recalling da Vinci S and Si Monopolar Curved Scissors Instruments following increased complaints of broken or frayed grip cables in reusable instruments.
Medline is recalling ENFit G-tube connectors because they were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices.
Medtronic is recalling MiniMed 630G insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.
Civco is recalling the eTRAX Needle System Starter Kit 18G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.
Medline is recalling kits containing ENFit G-tube connectors because the connectors were not made to required dimensional specifications and may not form a proper seal.
Civco is recalling the eTRAX Needle Sensor 12G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.
Medline is recalling the Anterior Hip Pack because it contains recalled Olympus biopsy valves, where rubber fragments may detach from the valve slit during use.
Intuitive Surgical is recalling da Vinci S and Si Double Fenestrated Grasper Instruments following increased complaints of broken or frayed grip cables in reusable instruments.
Philips has identified instances where X-ray imaging on the Azurion 7 M20 may not initiate, or may run intermittently, when the wired foot switch is used. 5,167 units are affected.
Medline is recalling four bronchoscopy and laryngoscopy kits because they contain recalled Olympus biopsy valves, where rubber fragments may detach from the valve slit during use.
One Paradise Ultrasound Renal Denervation catheter was distributed although it was a nonconforming product that should have been scrapped and not used in humans.
Philips is recalling the Allura Xper FD20 Biplane because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Stryker is recalling the CHROMOPHARE Softlit Ring Surgical Light System because the light assembly may not adequately support the weight of the ceiling cover.
Philips is recalling the Allura Xper FD20/15 OR Table because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Medtronic is recalling MiniMed 700G insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.
Intuitive Surgical is recalling da Vinci S and Si Tenaculum Forceps Instruments following increased complaints regarding frayed or broken pitch cables on reusable surgical instruments.
Recor Medical is recalling one lot of the Paradise Ultrasound Renal Denervation System Catheter because a nonconforming product that should have been scrapped was distributed instead.
Intuitive Surgical is recalling da Vinci S and Si Grasping Retractor Instruments following increased complaints of broken or frayed grip cables in reusable instruments.
Philips is recalling the Azurion 3 M15 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
The 2.4 VOLT Tap Cortex Screw is being recalled after a full lot swap with the VOLT Locking Screw Tap left the bone taps with an incorrect thread.
Civco is recalling the eTRAX Needle System Starter Kit 12G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.
Mentor is recalling CPX 4 US Breast Tissue Expanders with Suture Tabs in the SILTEX low height range because the infusion sets may contain a dull or blunt needle tip.
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