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.
Stryker is recalling the CHROMOPHARE Softlit Ring Surgical Light System because the light assembly may not adequately support the weight of the ceiling cover.
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.
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.
Medline is recalling BAL and ENDO kits because they contain recalled Olympus biopsy valves, where rubber fragments may detach from the valve slit during use.
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.
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.
The Finesse BTK Multicath injectable angioplasty balloon catheter is being recalled because of the potential for the balloon not to meet burst specifications.
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 FD10/10 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Civco is recalling the eTRAX Needle Sensor 14G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.
Burlington Medical is recalling leg wraps because of the potential for attenuation degradation over time, decreasing the lifespan of the product.
Medtronic is recalling MiniMed 720G 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 Azurion 5 M20 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Burlington Medical is recalling protective sleeves made with Xenolite 800 attenuation material because of the potential for attenuation degradation over time.
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.
Burlington Medical is recalling frontal aprons made with Xenolite 800 attenuation material because of the potential for attenuation degradation over time.
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 smooth tall height range because the infusion sets may contain a dull or blunt needle tip.
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.
Burlington Medical is recalling kilts made with Xenolite 800 attenuation material because of the potential for attenuation degradation over time.
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.
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.
Philips is recalling the Allura Xper FD10C because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Medtronic is recalling Paradigm REAL-Time 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 Sensor 16G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified on the user interface.
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