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.
IBA Dosimetry GmbH is recalling the myQA iON dosimetry device (Article Number MQ10-000) because creating two structures with identical names except for a special character causes wrong analysis results.
Boston Scientific is recalling 435 IceSeed 1.5 CX S cryoablation needles manufactured between April 2024 and February 2025 that were programmed with DEMO settings instead of Commercial settings, which can cause the Cryoablation System to prompt repeated tests if the needle is disconnected and reconnected.
Boston Scientific is recalling IceSeed 1.5 CX cryoablation needles manufactured between April 2024 and February 2025 because they were programmed with demo settings instead of commercial settings. If disconnected and reconnected during use, the system will prompt unnecessary recalibration testing.
Defibtech is recalling Automated External Defibrillators Model DDU-2300 distributed in Switzerland because Italian-language labeling and instructions were not included, violating Swiss Medical Devices Ordinance requirements.
Siemens Healthcare Diagnostics is recalling epoc BGEM Crea Test Card (25 pk) units due to discrepant high pH results in samples with higher injection volumes. The recall affects 5,207 units distributed nationwide and internationally.
Medline procedure kits containing sterile water and 0.9% normal saline bottles are being recalled because the bottles leak at the peel-foil and bottle opening interface. The kits were distributed worldwide including the US, Panama, and Canada.
Boston Scientific is recalling IceSeed 1.5 CX S cryoablation needles manufactured April 2024 to February 2025 that were programmed with DEMO instead of Commercial settings. If disconnected and reconnected after initial testing, the system will re-prompt testing rather than functioning normally.
Medline Sterile Water, USP 100mL bottles are being recalled because they leak at the interface between the peel-foil and bottle opening, posing a contamination risk.
Medline Industries is recalling Sterile Water and Sterile 0.9% Normal Saline bottles due to leaking at the peel-foil and bottle opening interface. The affected kits were distributed nationwide and internationally.
Medline Sterile 0.9% Normal Saline 100mL bottles are being recalled because they may leak at the interface where the peel-foil meets the bottle opening. The bottles were distributed nationwide in the US and in Panama and Canada.
Defibtech, LLC is recalling one Automated External Defibrillator Model DDU-2450 (German language version) distributed in Switzerland because it lacks required Italian language labeling and instructions for use.
Medline procedure kits containing Sterile Water and Sterile 0.9% Normal Saline bottles are being recalled because the bottles leak at the peel-foil and bottle opening interface.
Defibtech is recalling Automated External Defibrillators Model DDU-2200 distributed in Switzerland due to missing Italian translation of product labeling and instructions, which violates Swiss Medical Devices Ordinance requirements.
Defibtech is recalling semi-automated external defibrillators (Models DDU-100 and DDU-100E) distributed in Switzerland because they lack required Italian language labeling and instructions for use.
Defibtech is recalling Automated External Defibrillators Model DDU-2200 distributed in Switzerland because they lack required Italian language labeling and instructions for use.
Abbott is recalling the Amplatzer TorqVue LP Catheter (Model 9-TVLPC4F90/080) due to a potential small breach in the proximal shaft that may not be visible and could lead to prolonged procedures, blood loss, or air embolism.
Conavi Medical Inc. is recalling the Novasight Hybrid Catheter (Model TA-06-0001) due to manufacturing issues that could cause the catheter sheath to detach. The device is used for diagnostic intravascular imaging.
Abbott is recalling specific lots of the Amplatzer TorqVue LP Delivery System due to a possible small breach in the shaft that is not visible but could lead to prolonged procedures, blood loss, or air embolism.
The mounting hardware supplied with the Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount does not provide adequate thread engagement to support the weight of the frame and monitor, creating a risk of hardware failure and separation.
CareFusion's BD PYXIS MEDBANK and MEDFLEX automated dispensing cabinets may experience a software issue during bin restocking that doubles bin quantities, potentially delaying access to medications and supplies.
Philips is recalling Brilliance CT Big Bore computed tomography systems due to unintended motion in the interventional control that may cause the gantry or table to collide with operators or patients.
Philips is recalling Zenition 50 medical imaging devices because the wireless foot switch pedal may get stuck in the active position, causing unintended radiation emission.
A specific lot of Stryker Latitude Humeral Trial Stems has incorrect laser marking and color indicator, potentially resulting in implantation of the wrong device size and orientation.
Medtronic MiniMed is recalling InPen smart insulin pens that may have been incorrectly assembled, potentially causing the insulin cartridge to not fit or the cartridge holder to be difficult to remove. Users without backup insulin could experience temporary hyperglycemia.
Philips North America is recalling Veradius Unity foot switch pedals that may become stuck in the active position, causing unintended radiation emission during medical procedures.
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