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.
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 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 measure radiation exposure inaccurately, potentially outside the specified +/-5.5% accuracy range. The issue involves the optical stimulated luminescence material used to detect radiation.
Instrumentation Laboratory is recalling ACL TOP coagulation analyzers due to potential sample misidentification that could result in incorrect test results and alter patient management decisions.
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.
Landauer is recalling nanoDot D2DNN radiation dosimeters because some units may have measurement accuracy outside their specified +/-5.5% range. Worldwide users should contact the manufacturer to verify device performance.
Landauer is recalling certain nanoDot radiation dosimeters worldwide due to a potential flaw in the optical stimulated luminescence material. Affected devices may provide inaccurate radiation dose readings.
Landauer recalled nanoDot C radiation dosimeters due to potential accuracy errors in the optical stimulated luminescence material. Affected units may provide dosimetry readings outside the specified tolerance range of +/-5.5%.
Landauer recalls nanoDot D2DNN radiation dosimeters worldwide due to potential accuracy degradation that may cause incorrect exposure readings.
Landauer is recalling nanoDot radiation dosimeter kits (16,760 units distributed worldwide) because some units may measure radiation exposure outside specified accuracy tolerances, potentially affecting dose measurement accuracy.
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 nanoDot D2DNN radiation dosimeters worldwide because some units may have measurement accuracy outside the specified +/-5.5% range. Approximately 36,805 units are affected.
Landauer is recalling NanoDots radiation monitoring dosimeters worldwide due to potential accuracy defects. Some units may fall outside the specified +/-5.5% accuracy range.
Landauer is recalling QC (Cs-137) nanoDot D2DNS radiation dosimeters worldwide because some units may operate outside the specified accuracy range. The recall affects 10,741 units with all batch numbers.
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.
Keystone Industries recalls Copaliner Cavity Varnish after discovering bottles of Copaliner Solvent were accidentally packaged in boxes labeled as varnish. The error affected 337 units distributed worldwide.
Advance Medical Designs is recalling 117,875 procedural kits containing ultrasonic transmission gel due to mislabeling of use instructions. The recall affects kits distributed to the United States, Canada, United Kingdom, 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.
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.
Baxter Healthcare is recalling the Welch Allyn Connex Spot Monitor due to improper placement of copper tape on the back of the liquid-crystal display. The device was distributed in California.
Advance Medical Designs is recalling procedural kits containing ultrasonic transmission gel because the product labeling does not accurately indicate appropriate use. The recall affects 460 units distributed to the US, Canada, UK, Panama, and Netherlands.
Advance Medical Designs is recalling 50-GEL20 ultrasound gel (13,750 units, lot 21043C2328) due to mislabeling with inappropriate use instructions. The product was distributed in the US, Canada, UK, Panama, and the Netherlands.
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.
Microbiologics Inc is recalling one lot of KWIK-STIK ANA QC sets missing one of three bacterial strains required for microbiological testing.
Aomori Olympus Co., Ltd. recalls 1,048 Olympus Distal Attachment units used in EMR kits due to di-2-ethylhexyl phthalate (DEHP) exceeding permissible exposure limits per ISO 10993-17: 2002. Devices were distributed nationwide.
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