Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 25–33 of 33 recalls
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification.…
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification.…
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification.…
Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device, rather than the packaged 6F version.
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.
Due to a potential open seal in the sterile barrier packaging .
Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.