Category
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.
Cardinal Health is recalling In-View Clear Leggings Sterile because a manufacturing variance causes the plastic film to stick, potentially preventing proper application.
Baxter Healthcare is recalling 1,650 Prismaflex Control Units used for renal replacement therapy because tubing performance variability may cause alarms during or after system self-tests.
Cardinal Health is recalling 936 units of sterile femoral angiography drapes because a manufacturing variance causes the plastic film to stick, preventing proper application.
Corin Ltd is recalling 23 units of the Trinity Acetabular System because the size indicated on the packaging and patient stickers is incorrect.
Cardinal Health is recalling In-View Clear Leggings because a manufacturing variance causes the plastic film to stick, preventing proper application.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 4 and Fe Slides because TIBC results may be approximately 80 ug/dL lower than expected.
Baxter Healthcare is recalling Prismaflex Control Units because tubing variability may cause alarms during self-tests. The units are used for Continuous Renal Replacement Therapy.
Siemens is recalling 29 interventional fluoroscopic X-ray systems because the power supply may cause the computer to shut down unexpectedly.
Medtronic is recalling 4 units of Custom Perfusion Packs due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.
Merit Medical Systems is recalling 587 HeartSpan Transseptal Needles because the labeled tip curvature may not match the actual curvature, posing a risk of unintended anatomy puncture.
Medtronic is recalling 70 units of Affinity Pixie Cardiotomy/Venous Reservoirs due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.
Medtronic Perfusion Systems is recalling three units of its Custom Perfusion System because they may contain elevated levels of bacterial endotoxins. Patients exposed to these devices could develop an acute inflammatory response.
Merit Medical Systems is recalling Heartspan Transseptal Needles because the labeled tip curvature may not match the actual curvature, posing a risk of unintended anatomy puncture.
Medtronic is recalling 5 units of Affinity Pixie Cardiotomy Reservoirs due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.
Imactis is recalling 105 NaviKit-stereotaxic accessories due to a mechanical defect in the needle holder that may cause inaccurate needle positioning during use.
Medtronic is recalling Affinity Pixie Oxygenators due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses in patients.
Canon is recalling 145 INTERVENTIONAL ANGIOGRAPHY SYSTEMS because table fastening bolts may loosen, causing the table to tilt.
Medtronic Perfusion Systems is recalling 7 units of the Custom Perfusion System because they may contain elevated levels of bacterial endotoxins, which can cause acute inflammatory responses in patients.
Siemens is recalling ADVIA Centaur4P Herpes-2 IgG test kits due to stability and calibration failures that may cause false positive results.
Philips is recalling 109 CT systems because a defect in the Incisive CT couch actuators could cause the couch to fail to self-lock and move downward unexpectedly.
Medtronic is recalling 10 units of the Affinity Pixie Cardiotomy/Venous Reservoir due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.
Epimed International is recalling Feth-R-Kath Catheters because the outer coating may crack or flake off. The recall covers 5,835 units distributed nationwide.
Siemens is recalling specific software versions for SOMATOM CT systems due to sporadic errors that may interrupt scanning workflows and delay diagnosis.
Philips is recalling 105 Incisive CT Computed Tomography X-ray Systems because gantry actuators may fail, causing the gantry to tilt forward.
Mindray is recalling 1,938 BeneVision Distributed Monitoring Systems because they may intermittently freeze, causing telemetry data to stop communicating to the central system.
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