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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.
Caire Inc. is recalling 70 CAIRE Liberator 45 liquid oxygen systems due to inconsistencies in weld penetration on the inner bottle's longitudinal weld seam discovered during an audit.
Sensititre MDRGN3F antibiotic test device may return false susceptible results for certain gram-negative bacteria, risking inappropriate antibiotic treatment. FDA Class I recall issued.
Caire, Inc. is recalling 10 CAIRE Liberator 45 liquid oxygen system units due to inconsistencies in weld penetration on the inner bottle discovered during an FDA audit.
The FDA recalled Sensititre GN6F Gram Negative antimicrobial susceptibility test plates (2,471 units) because they may report false results indicating bacteria are susceptible to certain antibiotics when they are actually resistant.
Remel Inc. recalled 8,073 units of Sensititre GN7F antibiotic susceptibility test plates after discovering they may report false results for certain bacteria, potentially leading to incorrect antibiotic treatment decisions.
Full Vision Inc. Trackmaster treadmills have a rare circuit defect that may prevent the safety tether from stopping the machine during a fall.
Cardinal Health is recalling Dover Closed Urethral Catheter Trays due to potential blockage of the urinary drainage bag inlet port, which may prevent proper urine drainage and increase the risk of urinary retention.
Cardinal Health is recalling Dover Closed Urethral Tray urinary drainage systems due to potential blockage of the drainage bag inlet port, which may prevent proper bladder emptying and increase the risk of urinary retention.
Full Vision Inc. is recalling 38 TrackMaster TMX428 220V treadmills due to a rare circuit failure that may prevent the magnetic safety tether from stopping the machine during a fall.
Integrity Implants recalls 1,369 spinal implant screws due to potential weld separation between components. No injuries have been reported.
LineSider Spinal System screws are recalled due to potential weld separation between components that could cause the Tulip Head to detach from the Screw Shank. The recall affects 1,227 screws distributed nationwide.
BD recalls CareFusion bipolar forceps (Ref F-5301) due to incomplete Instructions For Use. The IFU is missing information about power supply interface and cleaning and maintenance.
Integrity Implants is recalling 1,702 LineSider Spinal System pedicle screws due to potential weld separation between screw head components that could result in device failure.
Carefusion 2200 Inc is recalling 203 units of V. Mueller SEMKIN Bipolar Forceps due to incomplete Instructions for Use. The IFU is missing critical content related to power supply interface and cleaning/maintenance procedures.
Eight Full Vision Trackmaster treadmills may fail to stop if the magnetic safety tether is pulled during a fall, due to a PCB circuit defect in the tether control system.
Carefusion is recalling surgical bipolar forceps due to incomplete instructions for use. The missing information covers power supply interface and cleaning and maintenance procedures.
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.
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.
Arthrex Small Joint OATS Sets may contain the wrong size cannulated reamer. Surgeons should verify instrument sizes before use.
Philips is recalling 566 MR 7700 MRI systems nationwide. The gradient coil in these systems may overheat and produce fire or smoke.
Carefusion recalls V. Mueller bipolar forceps with incomplete instructions. The device lacks critical information on power supply interface and cleaning procedures.
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 2200 Inc is recalling 4,557 units of V. Mueller ADSON Bipolar Forceps due to incomplete Instructions for Use. The IFU is missing content about power supply interface and cleaning and maintenance instructions.
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.
Cardinal Health is recalling Dover closed urethral catheter trays because the drainage bag port may become occluded, preventing urine from draining properly and increasing the risk of urinary retention.
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