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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.
Siemens is recalling Artis zee floor MN systems because the display may fail to show images after power save mode, potentially requiring procedure cancellation.
RaySearch Laboratories is recalling RayStation Radiation Therapy Treatment Planning System software versions 6.0 through 7.0 because dose calculation accuracy may be less than expected in some situations.
St Jude Medical is recalling implantable cardiac devices to release new firmware that strengthens security against unauthorized access.
Siemens is recalling 14 Artis zee floor systems because the display may fail to show images after power save mode, potentially requiring treatment cancellation.
Siemens is recalling 73 Artis zee ceiling units because the display may fail to show images after power save mode, potentially requiring procedure cancellation.
Philips is recalling 28 Ingenuity Core128 MRI systems because a production defect in the X-Ray Tube allows oil leakage, posing a risk to patients and users.
Siemens is recalling Artis Q.zen floor units because the display may fail to show images after power save mode, potentially requiring procedure cancellation or patient transfer.
Siemens is recalling four Artis Q.zeego X-ray systems because the display may remain black after power save mode, preventing normal operation and requiring procedure cancellation or patient transfer.
St Jude Medical is releasing new firmware for Merlin PCS programmers to strengthen security against unauthorized access to cardiac devices.
Safe N Simple is recalling No-Sting Skin Barrier Film wipes due to confirmed bacterial contamination that poses a risk of infection.
Siemens is recalling five Artis Q biplanes because the display may fail to show an image after power save mode, potentially requiring procedure cancellation or patient transfer.
Toshiba is recalling 162 Aplio I-series diagnostic ultrasound systems because the power supply unit may be damaged and fail to start up.
Siemens is recalling two Artis zee biplane MN systems because the large display may fail to show an image after power save mode, potentially requiring procedure cancellation or patient transfer.
Randox Laboratories is recalling Liquid Assayed Specific Protein Control - Level 2 because Free Kappa light chains increase over shelf life, potentially delaying diagnostic results.
Horiba Medical is recalling ABX Pentra Micro Albumin 2 CP reagents because they may produce elevated results if used immediately after a specific creatinine reagent.
St Jude Medical is recalling Ellipse ICDs and CRT-Ds to release new firmware that strengthens security against unauthorized access.
Randox Laboratories is recalling Liquid Assayed Specific Protein Control Level 1 because Free Kappa light chains increase over shelf life, potentially delaying diagnostic results.
BioMerieux SA is recalling VIDAS FSH assay kits due to invalid calibration errors. The recall affects 59 units distributed in the U.S.
St Jude Medical is recalling Fortify Assura implantable cardiac devices to release new firmware that strengthens security against unauthorized access.
St Jude Medical is recalling Unify ICDs and CRT-Ds to release new firmware that strengthens security against unauthorized access.
Draeger Medical is recalling 72 Apollo Anesthesia Machines because a fault could allow the device to deliver a hypoxic gas mixture to patients, posing a risk of death.
Draeger Medical is recalling 31 Fabius GS Tiro anesthesia machines because a fault could allow 100% nitrous oxide delivery, creating a risk of hypoxic mixtures and patient death.
Draeger Medical is recalling four Fabius GS MRI Anesthesia Machines because a fault could allow the device to deliver a hypoxic gas mixture to patients, potentially causing death.
Draeger Medical is recalling 62 Fabius GS Premium Anesthesia Machines because a fault could allow the device to deliver a hypoxic gas mixture to patients.
Zimmer Biomet is recalling 11 trauma guide wires due to packaging defects that may compromise sterility, posing an infection risk.
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