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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.
Philips is recalling 566 Ingenia Elition X MRI systems nationwide. The gradient coil may act as a heat source with the potential to produce smoke and/or fire.
Integrity Implants recalls 1,369 spinal implant screws due to potential weld separation between components. No injuries have been reported.
Full Vision Inc. Trackmaster treadmills have a rare circuit defect that may prevent the safety tether from stopping the machine during a fall.
BD recalled Carefusion bipolar forceps due to missing Instructions for Use content regarding power supply interface and cleaning/maintenance. Affected units distributed nationwide and internationally.
Getinge Flow-c and Flow-e anesthesia systems are recalled due to backup battery defects that may fail during power outages, potentially requiring manual emergency ventilation. 65 units affected in six US states.
Integrity Implants Inc. is recalling LineSider Spinal System pedicle screws (Model LS-N6SG6545) due to potential screw head separation at the weld location during surgery. This Class II recall affects units distributed to California, Indiana, New York, Oklahoma, and Washington DC.
Philips is recalling 566 MR 7700 MRI systems nationwide. The gradient coil in these systems may overheat and produce fire or smoke.
BD is recalling Carefusion V. Mueller Bipolar Forceps due to incomplete Instructions for Use lacking critical content about power supply interface and cleaning procedures.
CareFusion bipolar forceps recalled nationwide due to incomplete Instructions for Use missing power supply interface and cleaning information. The missing content could affect proper device operation and maintenance.
Cardinal Health is recalling Dover urinary catheter trays due to potential blockage of the drainage bag inlet port, which may prevent urine drainage and increase the risk of urinary retention.
CareFusion V. Mueller bipolar forceps (Ref F-5073) recalled due to missing critical instructions for power supply interface and cleaning and maintenance procedures. Users should obtain the complete Instructions For Use from the manufacturer.
Carefusion is recalling 218 units of surgical bipolar forceps due to incomplete product instructions. The Instructions For Use is missing information about power supply interface and cleaning/maintenance procedures.
Carefusion recalled 84 units of HARDY-STYLE BAYONET BIPOLAR FORCEPS nationwide and internationally due to incomplete Instructions for Use. The distributed documentation is missing information about power supply interface, cleaning, and maintenance procedures.
CareFusion V. Mueller bipolar forceps are being recalled because the provided Instructions for Use are missing critical content about power supply interface and cleaning/maintenance. The complete information is available in the manufacturer's full IFU.
Carefusion is recalling neurosurgical bipolar forceps due to incomplete Instructions for Use. The product is missing critical information about power supply interface and cleaning/maintenance procedures.
Philips is recalling certain Ingenia Elition S MR Systems due to a potential fire or smoke hazard from the gradient coil. The affected units are distributed nationwide in the United States.
CareFusion is recalling 1369 units of V. Mueller bipolar surgical forceps (Model F-1000) due to incomplete instructions for use. The provided instructions lack information about power supply interface and cleaning and maintenance procedures.
Siemens is recalling two lots of its IMMULITE Total Testosterone Assay due to a confirmed 40% positive measurement bias at higher testosterone levels, which may delay diagnosis and require repeat testing.
Philips is recalling the Upgrade to MR 7700 System (Model 782130) because the gradient coil may act as a heat source and produce smoke or fire. Affected units should not be operated until Philips provides further guidance.
Carefusion bipolar surgical forceps recalled due to incomplete Instructions for Use missing critical content on power supply interface and maintenance procedures. Distributed nationwide and internationally.
Carefusion is recalling surgical bipolar forceps due to incomplete instructions for use. The missing information covers power supply interface and cleaning and maintenance procedures.
Randox Laboratories recalls IgM and IgA immunoturbidimetric assay kits due to carryover contamination that can cause elevated test results when run immediately after Fructosamine tests on RX instruments.
Cardinal Health recalls Dover Closed Urethral Tray due to potential blockage of the urinary drainage bag inlet port that could prevent urine drainage and increase risk of urinary retention if bladders are not emptied timely.
Full Vision Inc. is recalling 165 TrackMaster treadmills due to a circuit defect in the magnetic safety tether that may prevent the equipment from stopping when a user falls.
Philips SmartPath to Ingenia Elition X MR System models may produce smoke or fire due to gradient coil heat. Recall affects 566 units nationwide.
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