Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 649–660 of 1,125 recalls
Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis…
Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis…
Their is the potential for weak staining which may result in false negative CD20 identification.
Their is the potential for weak staining which may result in false negative CD20 identification.
Their is the potential for weak staining which may result in false negative CD20 identification.
Dipstick strep A test has potential for false positive results.
Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.
Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon.…
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon.…
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon.…
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon.…