Cook Inc.
188 recalls on record · Latest: Dec 29, 2021
FDA Devices Moderate Feb 21, 2018
Central Venous Tray Triple Lumen Polyurethane Catheter, Catalog Identifier: C-UTLMY-501J-CCT Product Usage: The central venous catheter is design…
FDA Devices Moderate Feb 21, 2018
Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane, Catalog Identifiers: C-UTLM-501J-25-6.5-WCE-BH, C-UTLM-501J-BH Product Usage…
FDA Devices Moderate Jun 21, 2017
Clarke-Reich Laparoscopic Knot Pusher
FDA Devices Moderate Jun 21, 2017
Stamey Needle
FDA Devices Moderate Jun 21, 2017
Endoscopic Introducer/Extractor
FDA Devices Moderate Jun 21, 2017
Pereyra-Raz Ligature Carrier
FDA Devices Moderate Jun 21, 2017
OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Product Usage: Used with the Odyssey 30 …
FDA Devices Moderate Jun 21, 2017
Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
FDA Devices Moderate Jun 14, 2017
Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas …
FDA Devices Moderate Jun 14, 2017
LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during endoscopic …
FDA Devices Moderate Jun 14, 2017
Willscher Vas Reapproximator Plate, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the va…
FDA Devices Moderate Mar 8, 2017
Micropuncture Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended …
FDA Devices Moderate Mar 8, 2017
TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The TriForce Peripheral Crossing Set is i…
FDA Devices Moderate Mar 8, 2017
Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
FDA Devices Moderate Mar 8, 2017
Check-Flo Performer Introducer, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction o…
FDA Devices Moderate Mar 8, 2017
Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introducti…
FDA Devices Moderate Mar 8, 2017
Check-Flo Introducer Hausdorf-Lock Atrial, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for int…
FDA Devices Moderate Aug 31, 2016
Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 in…
FDA Devices Moderate Aug 31, 2016
Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 …
FDA Devices Moderate Aug 31, 2016
Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained an…
FDA Devices Moderate Aug 31, 2016
Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by…
FDA Devices Moderate Aug 31, 2016
FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used for instillation of contrast media into the uterine cavity…
FDA Devices Moderate Aug 31, 2016
Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic
FDA Devices Moderate Mar 30, 2016
Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set The Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set consists of a radiopaque balloon catheter …
FDA Devices Moderate Mar 9, 2016
Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization Needle consists of a bevel-tip needle with centimeter markings and a …
FDA Devices Moderate Mar 2, 2016
Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-t…
FDA Devices Critical Mar 2, 2016
Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Pr…
FDA Devices Critical Mar 2, 2016
Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and …
FDA Devices Critical Mar 2, 2016
Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated c…
FDA Devices Moderate Dec 23, 2015
VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain.
FDA Devices Moderate Nov 18, 2015
Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.
FDA Devices Critical Aug 12, 2015
Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of cont…
FDA Devices Critical Aug 12, 2015
Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and ca…
FDA Devices Critical Aug 12, 2015
Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast medi…
FDA Devices Moderate Jul 29, 2015
Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular Intrahepatic Access Sets are intended for transjugular liver acces…
FDA Devices Moderate Jul 1, 2015
LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical…
FDA Devices Critical Sep 3, 2014
CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterilizable outer package and is supplied one pouch in a box. T…
FDA Devices Critical May 22, 2013