Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 85–96 of 426 recalls
Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the f…
The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.
Potential for the Cassette Loading Lever to break.
Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore r…
Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.
Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2.…
A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process;…
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples.…
Includes an incorrect screw seat interface.
Includes an incorrect screw seat interface.