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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.
Boston Scientific's HOT AXIOS stent delivery system may have an outer sheath that detaches and prevents proper stent expansion. The defective tip can remain around the stent, requiring device exchange during the procedure.
Zimmer, Inc. is recalling NexGen LCCK knee implant articular surface components due to incorrect assembly of the metal support post. The defect was identified internally in a small number of units.
Karl Storz is recalling 221 cysto-urethroscopes because their reprocessing instructions have not been FDA-approved. Medical facilities should stop using these devices until receiving updated instructions from the manufacturer.
Karl Storz uretero-renoscope devices are being recalled because their instructions for reprocessing and sterilization have not been FDA-reviewed or approved. This poses a potential patient safety risk.
Edifier speakers in Draeger's Infinity Central Station may not produce audible alarms when in analog mode, potentially delaying patient treatment. Approximately 1,013 units are affected worldwide.
Snap rings may detach from internal shafts in CyberKnife Treatment Delivery Systems, potentially causing uncontrolled rotation on treatment axes. This affects 212 units distributed worldwide for stereotactic radiosurgery.
Boston Scientific is recalling HOT AXIOS Stent systems because the outer sheath's tip can detach and prevent proper stent expansion, requiring device replacement during procedures.
Alphatec Spine is recalling Calibrate CCX spinal implants used in fusion procedures after receiving complaints of post-operative implant collapse. Approximately 1,511 implants were distributed nationwide.
LivaNova's SenTiva DUO vagus nerve stimulation device may stop delivering therapy due to an internal component issue. The recall affects 84 units distributed worldwide.
Siemens ARTIS One X-ray systems may deliver higher radiation doses during first imaging after patient registration due to copper prefiltration malfunction occurring in very rare situations.
Medline Industries recalls certain Sterile Infusion Catheters labeled as having antimicrobial heparin coating but lacking this coating. Affected units were either distributed directly or incorporated into medical convenience kits.
Boston Scientific is recalling HOT AXIOS Stent systems due to potential outer sheath detachment that can prevent proper stent expansion. This defect may require device replacement during the procedure.
Karl Storz Endoskope Uretero-Renoscope (Model 27011L) is recalled due to Instructions for Use containing reprocessing procedures that have not been FDA-reviewed or approved. The recall affects 5 units distributed nationwide.
Medline's CENTURION infusion catheters in certain lots lack the antimicrobial heparin coating they are labeled as having. The mislabeled catheters were distributed to healthcare facilities in eight states.
The AXIOS Stent and Delivery System is being recalled because the outer sheath can detach and prevent proper stent expansion, requiring device replacement during the procedure.
Karl Storz is recalling its Ureteroscope (Model 27001K) because the Instructions for Use contain reprocessing procedures that have not been reviewed or approved by the FDA. All 185 units distributed nationwide are affected.
Boston Scientific is recalling 1,144 AXIOS Stent Delivery System units because the outer sheath's distal black tip can detach. If this occurs, the tip may remain around the stent saddle and prevent proper stent expansion, requiring device exchange.
Boston Scientific's AXIOS Stent Delivery System (47 units affected) is recalled because the outer sheath can detach and prevent proper stent expansion, requiring device exchange.
Karl Storz Endoscopy is recalling its Pediatric Uretero-Renoscope 7.3 Fr. due to unapproved reprocessing instructions. The device instructions contain procedures not reviewed or approved by the FDA for safety and efficacy.
Karl Storz Ureteroscope model 27000K is being recalled due to instructions for use containing reprocessing modalities not reviewed or approved by the FDA. The recall affects 82 units distributed nationwide.
Boston Scientific's HOT AXIOS stent delivery system has a defect where the outer sheath can detach and prevent proper stent expansion, requiring device replacement.
B. Braun Medical is recalling 1,090 units of the Design Options Combined Spinal/Epidural Tray due to an incorrect catheter connector that cannot securely connect to the epidural catheter, preventing medication administration.
The AXIOS Stent with Electrocautery-Enhanced Delivery System may have a defective outer sheath that can detach and prevent proper stent expansion, requiring device replacement during the procedure.
Boston Scientific recalls 1,399 units of AXIOS stent delivery systems due to outer sheath detachment that can prevent proper device expansion, requiring procedure prolongation and device exchange.
The muRata Vios Monitoring System Model 2050 bedside cardiac monitor has been recalled due to a software issue causing patient vital signs and ECG waveforms to flicker and become distorted on the Central Station Monitor. No injuries have been reported.
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