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.
Ortho Clinical Diagnostics is recalling two VITROS 250 Chemistry Systems due to a software anomaly that may cause unsuccessful calibration.
Medical Components, Inc. is recalling 6,830 hemodialysis catheter insertion kits because the tray labels incorrectly describe the included introducer as valved.
Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 32 due to a software anomaly that may cause unsuccessful calibration.
Philips is recalling 582 Brilliance 64 CT systems because images may be incorrectly labeled as having phase tolerance applied when it was not.
Medical Components, Inc. is recalling 6,830 hemodialysis catheter insertion kits because the tray labels incorrectly identify the included introducer as valved.
Philips is recalling 12 Ingenuity TF PET/CT systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.
Opternative Inc is recalling the Visibly Online Refractive Vision Test software because it lacks FDA 510(k) clearance. The software was distributed worldwide and in specific US states.
Ortho Clinical Diagnostics is recalling 30 VITROS 250AT Chemistry Systems due to a software anomaly that may cause unsuccessful calibration.
Ortho Clinical Diagnostics is recalling 30 VITROS 350 Chemistry Systems due to a software anomaly that may cause unsuccessful calibration.
Ra Medical Systems is recalling four DABRA Laser units because they failed to calibrate during setup. The devices were distributed in California and Pennsylvania.
Ortho Clinical Diagnostics is recalling 825 VITROS 4600 Chemistry Systems worldwide due to a software anomaly that may cause unsuccessful calibrations.
Philips is recalling 25 IQon Spectral CT systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.
Ortho Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to a software anomaly that may cause unsuccessful calibrations.
Howmedica Osteonics Corp. is recalling 11 Serrato polyaxial screws because some 90mm and 100mm units were manufactured with the wrong length.
Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 32 due to a software anomaly that may cause unsuccessful calibration.
Philips is recalling 128 iCT computed tomography systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.
Biomet 3i is recalling 17 units of Certain Bellatek Titanium Abutments because a manufacturing defect prevents the screw from seating correctly.
Siemens Medical Solutions is recalling Lantis systems due to a Microsoft Windows Remote Desktop Protocol vulnerability.
Philips is recalling Azurion interventional fluoroscopic X-ray systems because a cold restart may take up to 7 minutes, potentially delaying treatment.
Abbott Ireland Diagnostics Division is recalling 216 units of Alinity i Ferritin Reagent Kits due to a manufacturing issue that may cause bottle neck damage and instrument failure.
Siemens Medical Solutions is recalling 15 Lantis Commander units due to a Microsoft Windows Remote Desktop Protocol vulnerability.
Medical Components, Inc. is recalling 6,830 hemodialysis catheter insertion kits because the tray labels incorrectly identify the included introducer as valved.
Ortho Clinical Diagnostics is recalling 30 VITROS 250 Chemistry Systems due to a software anomaly that may cause unsuccessful calibrations.
Geistlich Pharma is recalling Bio-Oss Pen units because visible green plastic debris was found on the outer barrel when unscrewing the cap.
Centurion Medical Products is recalling 6,180 Driveline Management System 1 Daily Kits because sterile packaging may be compromised.
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