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.
Cardinal Health is recalling two lots of Monoject Tuberculin Syringes because the packaging identifies them as 1 mL Luer Lock tuberculin syringes but the contents are U-100 insulin syringes.
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.
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.
Burlington Medical is recalling BAT (Breast, Axilla and Thyroid) Coverage because of the potential for attenuation degradation over time.
Philips is recalling the Allura Xper FD20 OR Table because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
The Finesse BTK Multicath injectable angioplasty balloon catheter is being recalled because of the potential for the balloon not to meet burst specifications.
Philips is recalling the Allura Xper FD20/20 OR Table because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Philips is recalling the Allura Xper FD20/20 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
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.
Philips is recalling the Allura Xper FD20 Biplane OR Table because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
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.
Medtronic is recalling MiniMed 770G 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.
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.
Mentor is recalling the CPX 4 US Breast Tissue Expander with Suture Tabs, smooth low height 650 cc, because the infusion sets may contain a dull or blunt needle tip.
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.
Burlington Medical is recalling frontal aprons made with Xenolite 800 attenuation material because of the potential for attenuation degradation over time.
Philips is recalling the Azurion 7 B12 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
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.
Civco is recalling the eTRAX Needle System Starter Kit 14G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.
Siemens is recalling Atellica CH Enzymatic Hemoglobin A1c because results may be depressed when the RCRP reagent is processed on the same analyzer, with bias increasing over time.
Philips is recalling the Allura Xper FD20 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
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.
Medtronic is recalling MiniMed 670G 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 700G insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.
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