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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.
Medtronic Navigation is recalling 26,674 non-invasive shunt kits because returned devices were not adequately inspected for damage that could compromise sterility.
Accuray is recalling 84 CyberKnife Robotic Radiosurgery Systems to correct a potential safety issue related to upgrading the Treatment Delivery Software for the first generation IRIS Variable Aperture Collimator.
Medtronic Navigation is recalling 26,674 Tumor Resection Kits because returned devices may not have been properly examined for damage to ensure sterility.
Medtronic Navigation is recalling 26,674 single-use spine pedicle accessory kits because returned devices may not have been properly examined for damage to ensure sterility.
Medtronic Navigation is recalling single-use instrument trackers because returned devices may not have been properly examined for damage to ensure sterility.
Medtronic Navigation is recalling 26,674 single-use, disposable navigation devices because returned units were not adequately examined for damage that could compromise sterility.
Medtronic Navigation is recalling 26,674 biopsy needle kits because returned devices may not have been properly examined for damage to ensure sterility.
Elekta, Inc. is recalling 15 units of the MOSAIQ oncology information system because a dose rounding error may cause incorrect numeric data to be displayed on printed reports.
Medtronic Navigation is recalling single-use, disposable devices because returned items were not adequately examined for damage to ensure sterility.
Soma Access Systems is recalling 3,530 units of AxoTrack I Sterile Procedure Kits because the sterile packaging may fail before the expiration date.
Medtronic Navigation is recalling 26,674 single-use Ref Frame Driver Kits because returned devices may not have been properly examined for damage to ensure sterility.
Siemens is recalling six SimView NT simulation systems because a rare defect may prevent components from stopping, risking collision with patients or equipment.
Medtronic Navigation is recalling 26,674 disposable sterile devices because returned units may not have been properly examined for damage that could compromise sterility.
Medtronic Navigation is recalling 26,674 sterile percutaneous pins because returned devices may not have been properly examined for damage to ensure sterility.
Owens & Minor is recalling MediChoice Dual-Release Folding Walkers because the wheels may be loose, too tight, or fall off.
Nidek Inc is recalling 21 MC-500 Multicolor Laser Photocoagulators because the devices may fail to emit laser light or output lower power than programmed during retinal treatment.
Silver Star Brands is recalling Transport Chair and Rollator units because the wheel assembly may fail, resulting in damaged wheels.
Monteris Medical is recalling 234 SideFire Directional Laser Probes because the distal sapphire tip may separate from the probe.
Medtronic Navigation is recalling 26,674 single-use disposable devices because returned items were not adequately inspected for damage that could compromise sterility.
Synthes, Inc. is recalling six sterile titanium trochanteric fixation nails due to incorrect assembly that may compromise bone stability.
Monteris Medical is recalling 133 FullFire Diffusing Tip Laser Probes because the distal sapphire tip may separate from the probe.
Medacta USA is recalling 32 MectaLIF Oblique Handles because incorrect laser markings could lead to improper device insertion during surgery.
Medtronic Navigation is recalling 26,674 sterile O-Arm drapes because returned devices were not adequately examined for damage to ensure sterility.
Medtronic Navigation is recalling single-use Patient Tracker devices because returned units may not have been properly examined for damage to ensure sterility.
Medtronic Navigation is recalling 26,674 sterile drill bits because returned devices may not have been properly examined for damage that could compromise sterility.
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