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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.
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.
Certain GE CARESCAPE patient monitors may fail to power on after mains power loss during battery maintenance, potentially delaying recognition of patient condition changes.
Biomet recalled RingLoc hip acetabular cup components that may have been incorrectly assembled with a mismatched locking ring, potentially causing joint instability. Affected patients may require surgical intervention.
GE Healthcare medical monitors may fail to display following a power loss event after CPU battery replacement, potentially delaying patient condition recognition.
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 recalls 9 units of CROME VR MRI SureScan implantable cardioverter defibrillators due to a manufacturing weld crack that caused devices to fail quality control leak testing.
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 Medical Solutions is recalling AXIOM MULTIX MP radiographic X-ray tables due to a potential short circuit in the power supply that may cause overheating and fire. The recall includes 20 units with U.S. nationwide distribution.
Medtronic is recalling 82 implantable cardioverter defibrillators due to a manufacturing defect involving weld cracks discovered during quality control testing before distribution to patients.
GE Healthcare is recalling certain CARESCAPE Canvas patient monitors that may fail to display vital signs after a power loss if the CPU battery has been replaced. This could delay recognition of changes in patient condition.
Medtronic is recalling 3 MIRRO MRI DR SureScan implantable cardioverter defibrillators due to a manufacturing weld crack that caused devices to fail quality checks. The defect was detected during manufacturing before devices reached patients.
Medtronic is recalling 40 EVERA MRI S DR SureScan ICDs (Model DDMC3D4) due to manufacturing weld cracks that caused devices to fail leak tests. The defect was identified during manufacturing; no patient harm has been reported.
Siemens is recalling 4 AXIOM Vertix Solitaire medical imaging devices due to a short circuit in the touch display power supply that may cause overheating and fire. Units with serial numbers 1004, 1006, 1011, and 1014 are affected.
Medtronic is recalling 14 units of EVERA MRI S VR SureScan implantable cardioverter defibrillators (Model DVMC3D4) due to potential weld cracks discovered during manufacturing. No patient injuries have been reported.
Stryker is recalling 39 Hoffman LRF Wire Tensioner devices because the adjustment ring may loosen, preventing proper tension setting. No injuries reported.
Medtronic recalls 13 MIRRO MRI VR SureScan implantable cardioverter defibrillators (ICDs) due to a manufacturing weld crack. The defect was identified and caused device failure during the manufacturing leak check quality control test.
Medtronic is recalling five units of its EVERA MRI S DR SureScan implantable cardioverter defibrillator due to a manufacturing defect—a weld crack that caused failure during quality control testing.
Medtronic is recalling 4 COBALT VR MRI SureScan implantable cardioverter defibrillators due to a manufacturing defect involving a weld crack identified during quality control testing.
Siemens MULTIX TOP I PRO X-ray tables are recalled due to a power supply short circuit that may cause overheating and fire. Three units have been identified.
ASPEN SURGICAL is recalling 1,900 units of the Endoscopic Kittner Blunt Dissecting Instrument (Model KT-9101) due to a potential defect in the sterile barrier seal.
Medtronic recalled 14 COBALT HF QUAD CRT-D MRI SureScan implantable defibrillators due to a weld crack manufacturing defect detected during quality control testing.
Dental EZ Group is recalling certain Titan Scaler Tip (Perio, Model 261669) units due to an oversized tip holder condition that may prevent proper seating, creating a risk of injury during use.
Maquet Cardiovascular recalls VasoView HemoPro 2 vessel harvesting systems due to potential fluid ingress that may prevent or unintentionally activate cautery function. The recall affects 430,037 units distributed worldwide.
GE Healthcare recalls CARESCAPE B650 patient monitors that may fail to power on after mains power loss following CPU timekeeper battery replacement, potentially delaying recognition of patient condition changes.
Medtronic is recalling 26 MIRRO MRI DR SureScan Implantable Cardioverter Defibrillators due to a manufacturing defect involving a weld crack that could affect device function.
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