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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.
Burlington Medical is recalling protective sleeves made with Xenolite 800 attenuation material because of the potential for attenuation degradation over time.
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 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.
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 Tenaculum Forceps Instruments following increased complaints regarding frayed or broken pitch cables on reusable surgical instruments.
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.
Mentor is recalling Artoura Breast Tissue Expanders in the smooth ultra high profile range because the infusion sets may contain a dull or blunt needle tip.
Mentor is recalling textured Artoura Breast Tissue Expanders with integral injection dome because the infusion sets may contain a dull or blunt needle tip.
Burlington Medical is recalling wrap aprons made with Xenolite 800 attenuation material because of the potential for attenuation degradation over time.
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.
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.
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.
Olympus is recalling SOLTIVE Premium 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.
Burlington Medical is recalling leg wraps because of the potential for attenuation degradation over time, decreasing the lifespan of the product.
Burlington Medical is recalling half aprons because of the potential for attenuation degradation over time, decreasing the lifespan of the product.
Philips is recalling the Allura Xper FD10F because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Medtronic is recalling Paradigm REAL-Time Veo insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.
Philips is recalling the Allura Xper FD10/10 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Intuitive Surgical is recalling da Vinci S and Si Grasping Retractor Instruments following increased complaints of broken or frayed grip cables in reusable instruments.
Medline is recalling three bronchoscopy convenience kits because they contain recalled Olympus biopsy valves, where rubber fragments may detach from the valve slit during use.
Medline is recalling the Airway Exam Kit because it contains recalled Olympus biopsy valves, where rubber fragments may detach from the valve slit during use.
Ultradent Products is recalling one lot of Jiffy Original Composite Polisher Cups because the cups may crumble and break apart easily, which could delay patient treatment.
Medtronic is recalling MiniMed 530G insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.
Medtronic is recalling MiniMed 780G insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.
Medtronic is recalling Paradigm insulin pumps models MMT-712 and MMT-715 because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.
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