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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.
A software issue in BD Alaris System Manager version 12.5.1 may prevent the PC unit from connecting to the server, potentially affecting wireless data transmission. CareFusion 303, Inc. is recalling the affected software version nationwide.
BD Pyxis automated dispensing cabinets were shipped with socket-outlet power strips that lack IEC electrical certification, potentially exposing users to leakage currents and electric shock.
Certain Zyno Medical Z800 series infusion pumps contain faulty power supply modules that cannot charge the rechargeable battery. When unplugged from AC power, affected pumps may lack sufficient charge to operate.
Olympus has recalled 227 EasySuite 4K operating room systems worldwide due to incomplete documentation of earth leakage testing, which is required to confirm electrical current levels are within safety standards.
WOM Tube Set for Irrigation (1700 units, Lots 4030902 and 4030903) is recalled due to incorrect RFID tag data that causes an error message preventing use in endoscopic surgeries, potentially resulting in surgical delays.
Ortho-Clinical Diagnostics is recalling a calibrator kit with an incorrect expiration date that could bias lab results if used past its true expiration date.
Stryker recalled its Curved Cement Delivery Needle (Lot 6659783) due to expired product distribution. Three units were distributed to customers in Arkansas, California, Colorado, Florida, and Michigan.
The Life2000 Ventilator may fail to charge or experience intermittent charging behavior due to damage to the battery charger dongle. This FDA Class I recall affects approximately 2,510 units distributed nationwide.
Philips is recalling 307 SENSE XL TORSO COIL 3.0T units used in MR imaging systems worldwide due to potential for coils to overheat and cause patient burn injuries.
Inspire Medical Systems recalls the Model 3028 Implantable Pulse Generator due to a manufacturing defect causing electrical leakage and system malfunction that requires revision surgery. The recall affects 24 devices distributed in the US and Germany.
Philips is recalling SENSE XL TORSO COIL units used in MRI imaging because the coils may heat up excessively and cause patient burns. This FDA Class I recall affects 729 units distributed worldwide.
Philips recalled 14 SENSE XL Torso Coils worldwide due to potential overheating. The coils could heat up during use and cause patient burn injuries.
Medtronic is recalling 8 units of the COBALT XT HF CRT-D MRI SureScan implantable cardioverter defibrillator due to manufacturing defects identified during quality control testing.
Medtronic is recalling 11 units of the COBALT XT HF QUAD CRT-D MRI SureScan implantable cardioverter defibrillator due to a manufacturing defect involving weld cracks that failed quality control testing.
Siemens AXIOM MULTIX MP radiographic X-ray tables are being recalled due to a potential short circuit in the touch display's power supply unit that may cause overheating or fire. 12 units nationwide are affected.
Medtronic is recalling eight COBALT XT VR MRI SureScan implantable cardioverter defibrillators due to weld cracks that caused device failure during manufacturing.
Draeger recalls 34,102 Infinity M500 monitoring systems due to electrical safety noncompliance. The devices pose a potential risk of electrical shock, burns, and cardiac arrhythmia.
Medtronic is recalling 36 COBALT DR MRI SureScan implantable cardioverter defibrillators due to a weld crack manufacturing defect. The defect was identified during manufacturing quality checks.
Siemens recalls AXIOM MULTIX MT radiographic X-ray tables due to a short circuit in the power supply unit that may cause overheating and fire. 7 units are affected nationwide.
Mermaid Medical is recalling 190 D*Clot® HD Rotational Thrombectomy Systems worldwide due to failed sterility testing that indicates the sterility barrier may not be fully intact.
Siemens RAPIDPoint 500e software version 5.3 incorrectly labels capillary blood samples as arterial on laboratory information system displays, potentially leading to misinterpretation of results and diagnostic errors.
Medtronic is recalling five implantable defibrillators due to a manufacturing defect where weld cracks caused devices to fail quality testing. The defective devices were identified during manufacturing and did not reach patients.
CentriMag Primary Console units may completely shut down without alarm during power surges above 1.8kV, requiring emergency switch to backup circulatory support.
Nine Medtronic COBALT DR MRI implantable cardioverter defibrillators are recalled due to a weld crack that caused devices to fail manufacturing quality checks.
Certain GE CARESCAPE patient monitors may fail to power on after mains power loss during battery maintenance, potentially delaying recognition of patient condition changes.
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