Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) recall — FDA Z-2199-2023
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
23,306 detailed records are currently available in this category.
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.
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…
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…
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…
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…
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
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.
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.
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
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.
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
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