Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
Aeris Balloon Dilation Catheter
Bryan Medical
Devices were mislabeled.
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PEDIATRIC EP PACK, Model Number DYNJ45158A
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 Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ULTRASOUND PACK, Model Number DYNDH1112; b) PARA THORACENTESIS TRAY, Model Number DYNDH1165A; c) ULTRASOUND TRAY, Model Number DYNDH1204;
MEDLINE INDUSTRIES, LP - Northfield
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VNUS TRAY, Model Number DYNJ44410G; b) INTRAUTERINE TRNSFUSION -LF, Model Number DYNJ9048708I; c) PERI NEURO BLOCK PACK-LF, Model Number PHS762887001B; d) TVS4700 CUSTOM PACK, Model Number TVS4700;
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 Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: STERILE SET FOR IMPLANT-LF, Model Number OST011F
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 OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60
Olympus Corporation of the Americas
There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
ContourΒΏ next GEN Blood Glucose Monitoring System
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 DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
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.