Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 841–852 of 1,121 recalls
Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
Three is the potential for the retractors to puncture through the sterile packaging.
Three is the potential for the retractors to puncture through the sterile packaging.
There were reports of an increase in reactive negative controls and false positive results.
There were reports of an increase in reactive negative controls and false positive results.
Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim.…
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial…
The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial…