Aeris Balloon Dilation Catheter
Bryan Medical
Devices were mislabeled.
95,018 total recalls in our database
Bryan Medical
Devices were mislabeled.
MEDLINE INDUSTRIES, LP - Northfield
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
MEDLINE INDUSTRIES, LP - Northfield
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
MEDLINE INDUSTRIES, LP - Northfield
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.
MEDLINE INDUSTRIES, LP - Northfield
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy.
Olympus Corporation of the Americas
There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
Ascensia Diabetes Care US
Ascensia Diabetes Care has determined through customer complaints that 580 of 2900 meters from lot number DM01T033P are reconfigured from mg/dL to mmol/L. Among them, 579 meters distributed in the United States were packaged into the meter kit and had incorrect factory-set unit of measure where the meters display glucose results in mmol/L rather than mg/dL. The standard unit of measurement for the United States is mg/dL. If a consumer does not notice the incorrect unit of measurement, it is possible that the meters glucose measurement will be read as a lower blood glucose measurement than expected, and this may result in the patients glucose level remaining high, which can potentially lead to an injury requiring immediate medical intervention.
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy.
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Beckman Coulter Biomedical GmbH
A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results
There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc.
MEDLINE INDUSTRIES, LP - Northfield
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.