DREAMTOME 49-30MM/260CM Material Number: M00584010
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach
95,025 total recalls in our database
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach
Traverse rail carriage delivered with non-conforming screws are too short to ensure appropriate installation. There is potential that the screws are unable to secure the traverse rail appropriately and could loosen over time causing the rail system to fall, potentially causing injury to caregivers and/or patients
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach
Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach
Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach
Failed stability specifications for reagent kits that may result in false negative test results.
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Devices may lose functionality due to susceptibility to moisture ingress.
Bard Peripheral Vascular
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Bard Peripheral Vascular
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Boston Scientific
Sterility of device is compromised due to a sterile barrier breach
Bard Peripheral Vascular
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Bio-Rad Laboratories
Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications
Bio-Rad Laboratories
Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications