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.
Olympus is recalling Vanta VCR and VMR XRF analyzers because the LED warning lights may fail to illuminate during X-ray emission.
Medtronic is recalling 326 Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall covers units distributed in the US and several international countries.
Siemens Healthcare Diagnostics is recalling IMMULITE PSA kits worldwide because patient samples show an average negative bias of approximately -22%.
Implant Direct Sybron Manufacturing is recalling 17 SwishTapered Implants because the packaged extender was in the incorrect position, which may cause micro-leakage and infection.
Medtronic is recalling 185 units of Intact Disposable Wands because the sterile barrier was breached, compromising sterility.
Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall covers 320 units distributed worldwide.
Immuno-Mycologics is recalling 630 units of the Cryptococcal Antigen Lateral Flow Assay because specific lots have lower specificity, leading to reported false positive results.
Zimmer Biomet is recalling Vanguard Total Knee System femoral components because packaging labels may incorrectly identify the size or side of the implant.
Zimmer Biomet is recalling 16 Orthopedic Salvage System tibial bodies because labels incorrectly identify them as AVL Modular Proximal Tibia components.
Siemens Medical Solutions is recalling 62 Syngo.plaza PACS systems to install a software update that resolves several issues.
Ortho-Clinical Diagnostics is recalling VITROS Na+ Slides because they may produce biased results if stored on the analyzer for 10 days after minimum warm-up.
Siemens Medical Solutions USA is recalling 55 Mammomat Inspiration digital x-ray mammography systems due to a software error.
Philips is recalling one Allura Xper FD10 X-ray system because production errors left screws loose, potentially causing the C-arm to rotate uncontrolled.
Villa Radiology Systems LLC is recalling 66 Apollo DRF multi-function x-ray systems because a chain of faults led to an injury involving inadvertent movement activation.
Villa Radiology Systems LLC is recalling Juno DRF x-ray systems after an injury occurred due to a chain of faults involving physical barriers and labeling.
Philips is recalling two Allura Xper FD20/15 systems because production errors may cause C-arm screws to loosen, leading to uncontrolled rotation.
Villa Radiology Systems LLC is recalling 66 Apollo multi-function x-ray systems after an injury incident involving inadvertent movement activation and delayed emergency stop response.
Philips is recalling two Allura Xper FD20 C-arm systems because production errors left screws loose, posing a risk of uncontrolled rotation.
Roche Diabetes Care is recalling the Accu-Chek Connect app because software defects may cause incorrect insulin bolus recommendations, potentially leading to hypoglycemia.
Villa Radiology Systems LLC is recalling 66 Apollo EZ multi-function x-ray systems because a chain of faults caused an injury to a user.
Philips is recalling one Allura Xper FD20 unit because production errors left screws loose, which could cause the C-arm to rotate uncontrolled.
Soft Computer Consultants is recalling Softbank II software due to a software error that may produce incorrect results in transfusion services.
Roche Diagnostics is recalling 30 cobas b 123 POC systems because a software issue may prevent automatic quality control from running, potentially leading to undetected incorrect test results.
INO Therapeutics is recalling 45 INOmax DSIR Plus delivery systems because an out-of-tolerance manometer may cause inaccurate valve calibration.
Baxter Healthcare is recalling Phoenix Dialysis Machine Preventive Maintenance Kits due to incorrect silicone connectors that may cause fluid leaks.
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