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FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Olympus Corporation is recalling 4,181 units of the Olympus Thunderbeat 5mm surgical device due to continued reports of adverse events. The device was distributed across the U.S., Brazil, Canada, Germany, Mexico, and Japan.
Medline is recalling 4,757 surgical kits and packs due to calibration issues with sterilization equipment that could affect sterility assurance. No illnesses or injuries have been reported.
Medline Industries, LP is recalling 9,051 surgical device kits due to sterilization equipment calibration issues that could compromise sterility assurance levels. The recalled kits may not be adequately sterile despite undergoing validated sterilization processes.
Medline is recalling over 23,000 endoscopy procedure kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the devices.
Olympus Corporation is removing Thunderbeat surgical instruments worldwide due to continued reports of adverse events. The 5 mm, 45 cm pistol grip devices affected include all manufacturing lots.
Medline is recalling 2,740 surgical and biopsy convenience kits due to calibration issues with sterilization equipment that may have compromised product sterility. No injuries have been reported.
Baxter is recalling 5 Spectrum IQ infusion pumps distributed in Ohio due to incomplete testing, specifically missing occlusion alarm testing, which could affect medication delivery safety.
Medline is recalling 12,418 surgical convenience kits due to calibration issues with sterilization and packaging equipment that may compromise sterility assurance. No illnesses have been reported.
Medline is recalling 291 units of three burn care convenience kit models due to calibration issues with sterilization equipment that may impact product sterility. No illnesses or injuries have been reported.
Olympus has initiated a removal of Thunderbeat 5 mm surgical devices following continued reports of adverse events. The affected devices were distributed worldwide, including throughout the United States.
Medline is recalling 7,494 neurosurgery convenience kits due to sterilization equipment calibration problems that could impact sterility assurance. No illnesses or injuries have been reported.
Medica Capillary Tubes used in blood gas testing show a systematic positive bias of up to 20% in potassium measurements, resulting in false elevation results that could affect clinical decisions.
Medline is recalling surgical gowns due to calibration issues in sterilization and packaging equipment that could impact sterility assurance. No illnesses have been reported.
Medline is recalling labor and delivery surgical kits due to calibration issues in sterilization equipment that could compromise product sterility. The recall affects 27,320 units distributed nationwide and worldwide.
Stryker Corporation recalls MOLLI 2 surgical markers due to dislodgement risk when magnetized surgical tools are used during procedures. The company is updating product labeling to address the issue.
Medline Industries is recalling 1,496 Convenience Kits due to calibration issues with sterilization and packaging equipment. The calibration defects could compromise the sterility assurance of these surgical instrument kits.
Medline Industries recalls over 193,000 surgical packs due to sterilization equipment calibration issues that could compromise sterility assurance. No injuries have been reported.
Medline Industries is recalling 5,346 sterile surgical procedure kits due to calibration issues in sterilization equipment that may compromise sterility assurance. The kits were distributed nationwide.
Integra LifeSciences is recalling Medihoney Calcium Alginate wound dressings due to potential packaging failures that could breach the sterile barrier and increase infection risk.
Medline is recalling 4,853 surgical and ophthalmology convenience kits due to calibration issues with sterilization equipment that could compromise sterility assurance. No illnesses have been reported.
Medline Industries recalled five arthroscopy surgical kit models due to calibration issues with sterilization and packaging equipment that could compromise sterility assurance. The recall affects 175 units distributed nationwide.
Intuitive Surgical is recalling 12 Da Vinci 5 surgical systems due to a software error that can cause loss of user interface content on external monitors, potentially impairing surgeon visualization during minimally invasive procedures.
Medline is recalling approximately 39,315 surgical device kits due to calibration issues in sterilization equipment that could compromise device sterility. The affected kits are used in cardiac, vascular, and general surgical procedures.
Medline Industries is recalling 4,525 C-section surgical kits due to calibration problems with sterilization equipment that could affect sterility assurance. No injuries have been reported.
Medline is recalling five types of urology convenience kits due to calibration issues with sterilization equipment that may have compromised the sterility assurance of the devices. Approximately 59 units distributed nationwide are affected.
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