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.
Angiodynamics Inc. is recalling Bio-Stable 5F kits because a component may contain unsafe levels of bacterial endotoxins.
Roche Diabetes Care is recalling specific lots of Accu-Chek Aviva Plus test strips because they may produce biased results or fail to detect blood, potentially leading to incorrect user actions.
Angiodynamics Inc. is recalling BioFlo Midline kits because a component may contain unsafe levels of bacterial endotoxins.
Sun Med, LLC is recalling 30 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach and impacting air delivery.
Angiodynamics Inc. is recalling 23 boxes of BioFlo Midline kits because a component may contain unsafe levels of bacterial endotoxins.
Maquet Cardiopulmonary Ag is recalling specific lots of Aortic Arterial Cannulas because the de-airing plugs may break during removal.
Maquet is recalling Aortic Arterial Cannulas because de-airing plugs may break during removal. The defect could compromise the device's integrity during cardiopulmonary bypass.
Angiodynamics Inc. is recalling 86 boxes of Microintroducer Kits because a component may contain unsafe levels of bacterial endotoxins.
Datascope Corporation is recalling eight Maquet Cardiopulmonary Bypass Custom Tubing kits because the over-pressure safety valve may fail to allow flow.
Ion Beam Applications is recalling 19 Proteus 235 proton therapy systems to provide safety information to maintenance technicians regarding ion source replacement.
Sun Med, LLC is recalling 80 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially causing the port to detach and impacting air delivery.
Angiodynamics Inc. is recalling Bio-Stable 5F kits because components may contain unsafe levels of bacterial endotoxins.
Sun Med, LLC is recalling 5 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially detaching during use and impacting air delivery.
Ion Beam Applications is recalling Proteus ONE and Proteus Plus medical devices because unauthorized modifications or third-party accessories may pose a safety risk.
Philips is recalling 94 IntelliVue MX40 Patient Monitors because five warning statements are missing from the instructions for use.
Zimmer Biomet is recalling 169 Vanguard Knee System PS Tibial Bearings because the label master file was incorrectly set up, though the physical product is correctly marked.
Thermo Fisher is recalling 67 units of Remel SUPERPACK CS/ 500 SEG/FLASK because the product may fail performance testing for Staphylococcus aureus.
BioMérieux is recalling VITEK 2 Gram-Positive identification cards in Guadeloupe because a shipment experienced a temperature excursion exceeding acceptable limits.
BioMérieux is recalling PREVI Color Gram reagents shipped to Guadeloupe that experienced a temperature excursion exceeding acceptable limits.
Keystone Dental Inc is recalling 72 Prima Plus dental implants due to mislabeling. The devices were distributed to dental professionals in 14 US states.
Philips is recalling IntelliVue MX40 Patient Monitors because five warning statements are missing from the instructions for use.
BioMérieux is recalling Color Gram 2 stains in Guadeloupe after a shipment experienced a temperature excursion exceeding acceptable limits.
BioMérieux is recalling VIDAS TOXO IgG Avidity tests because a shipment to Guadeloupe exceeded temperature limits. The products were delivered to customers despite quarantine instructions.
BioMérieux is recalling VITEK 2 Neisseria-Haemophilus identification cards in Guadeloupe that were exposed to temperatures exceeding acceptable limits.
Cellavision AB is recalling CellaVision DM Software versions 6.0.1 and 6.0.2 due to a malfunction where cell comments are not sent to the Laboratory Information System.
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