Class IIOngoingZ-1786-2025
Cook Incorporated recalls Check=Flo Performer Introducer
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Cook IncorporatedINMay 28, 2025
Introducer, Catheter recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 13–16 of 16 recalls
Class IIOngoingZ-1733-2025
Galt Medical Corporation recalls B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model N…
Due to a potential open seal in the sterile barrier packaging .
Galt Medical Corporati…TXMay 14, 2025
Class IIOngoingZ-1434-2025
Merit Medical Systems, Inc. recalls Prelude IDEAL 4 F Hydrophilic Sheath Introducer
Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
Merit Medical Systems,…UTApr 2, 2025
Class IIOngoingZ-1048-2025
MEDLINE INDUSTRIES, LP - Northfield recalls CENTURION Infusion Catheter
Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.
MEDLINE INDUSTRIES, LP…ILFeb 5, 2025