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.
Medtronic Sofamor Danek USA Inc is recalling Magnifuse Bone Graft products due to incorrect size labeling on 55 pouches. Units with specific serial numbers were distributed in nine U.S. states.
Advance Medical Designs, Inc. is recalling 26,900 procedural kits containing ultrasonic transmission gel due to mislabeling of use instructions. The affected products were distributed in the U.S., Canada, the UK, Panama, and the Netherlands.
Landauer is recalling nanoDot D2DNS radiation dosimeters due to potential measurement inaccuracy. Some units may read outside the specified +/-5.5% accuracy range.
Landauer is recalling Calibrate nanoDot D2DNS radiation dosimeters worldwide due to a potential material defect that may cause readings to fall outside the specified ±5.5% accuracy range.
ACUSON Redwood 2.0 ultrasound systems may display underestimated measurement results when using an 18L6 transducer in Dual format, potentially leading to patient misdiagnosis. 796 units are affected worldwide.
Landauer is recalling 427 nanoDot radiation monitoring dosimeters that may provide inaccurate radiation exposure readings. Some units may fall outside the specified ±5.5% accuracy range due to a manufacturing issue.
One lot of Remel Todd Hewitt Broth culture medium may fail to recover Group B Streptococci during testing or use with patient samples, potentially resulting in missed diagnoses.
Landauer recalled nanoDot D2DNS radiation dosimeters worldwide due to potential inaccuracy in Optical Stimulated Luminescence material. Some units may read outside the specified ±5.5% accuracy range.
Landauer is recalling nanoDot D2DNS radiation dosimeters worldwide because some units may read outside the specified ±5.5% accuracy range due to a potential non-conformance in the Optical Stimulated Luminescence material.
Landauer is recalling nanoDot radiation dosimeter adapters (EU Model VINLADA003) worldwide because some units may provide dosimetry readings outside the specified +/-5.5% accuracy range due to a non-conformance in the optical measurement material.
Landauer recalled 135 nanoDot D2DNS radiation dosimeters worldwide due to potential accuracy deviations outside the specified ±5.5% range in optical stimulated luminescence material.
Landauer is recalling Calibrate nanoDot radiation monitoring dosimeters due to a potential defect in the optical luminescence material that may result in inaccurate radiation dose readings.
Landauer is recalling nanoDot D2DXN radiation dosimeters worldwide due to potential measurement inaccuracy. Some units may read outside the specified +/-5.5% accuracy range.
Landauer is recalling NanoDots radiation monitoring dosimeters worldwide due to potential accuracy defects. Some units may fall outside the specified +/-5.5% accuracy range.
Advance Medical Designs is recalling 1880 ultrasound gel procedural kits due to mislabeling that indicates inappropriate use. The affected kits were distributed in the US, Canada, UK, Panama, and the Netherlands.
Landauer has recalled nanoDot radiation dosimeters due to potential accuracy deviations in the Optical Stimulated Luminescence material used to measure radiation exposure. Affected units may read outside the specified +/-5.5% accuracy range.
Landauer is recalling NanoDots radiation monitoring dosimeters because some units may not meet specified accuracy of +/-5.5% due to a defect in the luminescence material.
Landauer is recalling 18,638 nanoDot radiation monitoring dosimeters worldwide. Some units may measure radiation exposure outside the specified ±5.5% accuracy range, potentially affecting occupational safety monitoring.
Landauer is recalling 147 nanoDot D2DNS radiation dosimeters worldwide due to potential non-conformance in the OSL material that may result in readings falling outside the ±5.5% accuracy specification.
Philips Allura and Azurion x-ray imaging systems are being recalled due to a damaged foot switch component that may prevent or intermittently disable x-ray radiation initiation. Approximately 19,115 systems are affected worldwide.
BeamAdjust software Version 2.3.3 generates incorrect calibration files when using TIFF or DICOM image reference data, affecting radiation measurement accuracy in OCTAVIUS Detector systems.
Landauer is recalling 211,815 nanoDot D2DNS radiation dosimeters worldwide. Some units may be outside the specified ±5.5% accuracy range due to a defect in the optical material, potentially resulting in inaccurate radiation exposure measurements.
Landauer is recalling nanoDot D2DNS radiation monitoring dosimeters due to a potential defect in the OSL material. Affected devices may provide radiation exposure readings outside the specified +/-5.5% accuracy range.
Advance Medical Designs is recalling ASG-001 ultrasound gel due to mislabeling of use instructions. The product was distributed in the US, Canada, UK, Panama, and Netherlands.
Keystone Industries is recalling 240 units of Henry Schein Hard Line Chairside Reline kits because the outer box is labeled as Soft Line, though the contents and instructions are correctly labeled.
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