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All Recalls

Every Cook Inc. Recall

Sorted by most recent. Click any recall for full details.

178 recalls
High RiskFDA
Cook Inc.
Central Venous Tray Triple Lumen Polyurethane Catheter, Catalog Identifier: C-UTLMY-501J-CCT Product Usage: The central venous cathet...
Surgical Devices·50 affected·Jul 31, 2017
High RiskFDA
Cook Inc.
Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane, Catalog Identifiers: C-UTLM-501J-25-6.5-WCE-BH, C-UTLM-501J-BH P...
Surgical Devices·75 affected·Jul 31, 2017
High RiskFDA
Cook Inc.
Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
Medical Devices·4,369 affected·May 9, 2017
High RiskFDA
Cook Inc.
OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Product Usage: Used with the...
Medical Devices·10,415 affected·May 3, 2017
High RiskFDA
Cook Inc.
Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabil...
Surgical Devices·327 affected·May 1, 2017
High RiskFDA
Cook Inc.
LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during...
Surgical Devices·327 affected·May 1, 2017
High RiskFDA
Cook Inc.
Willscher Vas Reapproximator Plate, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stab...
Surgical Devices·327 affected·May 1, 2017
High RiskFDA
Cook Inc.
Clarke-Reich Laparoscopic Knot Pusher
Medical Devices·178 affected·Apr 25, 2017
High RiskFDA
Cook Inc.
Stamey Needle
Medical Devices·698 affected·Apr 25, 2017
High RiskFDA
Cook Inc.
Endoscopic Introducer/Extractor
Medical Devices·46 affected·Apr 25, 2017
High RiskFDA
Cook Inc.
Pereyra-Raz Ligature Carrier
Medical Devices·257 affected·Apr 25, 2017
High RiskFDA
Cook Inc.
Micropuncture Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers a...
Surgical Devices·778 affected·Feb 1, 2017
High RiskFDA
Cook Inc.
TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The TriForce Peripheral Cross...
Medical Devices·1,875 affected·Feb 1, 2017
High RiskFDA
Cook Inc.
Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
Medical Devices·1,589 affected·Feb 1, 2017
High RiskFDA
Cook Inc.
Check-Flo Performer Introducer, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for in...
Surgical Devices·884 affected·Feb 1, 2017
High RiskFDA
Cook Inc.
Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended fo...
Surgical Devices·854 affected·Feb 1, 2017
High RiskFDA
Cook Inc.
Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement o...
Surgical Devices·5,020 affected·Apr 15, 2016
High RiskFDA
Cook Inc.
Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement...
Surgical Devices·148,334 affected·Apr 15, 2016
High RiskFDA
Cook Inc.
Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physician...
Surgical Devices·60,302 affected·Apr 15, 2016
High RiskFDA
Cook Inc.
Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic p...
Surgical Devices·532,395 affected·Apr 15, 2016
High RiskFDA
Cook Inc.
FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used for instillation of contrast media into the ut...
Medical Devices·1,881 affected·Apr 15, 2016
High RiskFDA
Cook Inc.
Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, clos...
Surgical Devices·25 affected·Jan 20, 2016
High RiskFDA
Cook Inc.
Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization Needle consists of a bevel-tip needle with centimeter mar...
Medical Devices·134 affected·Jan 8, 2016
CriticalFDA
Cook Inc.
Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated ...
Surgical Devices·2,280 affected·Jan 6, 2016
High RiskFDA
Cook Inc.
VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles ...
Surgical Devices·35 affected·Nov 19, 2015
High RiskFDA
Cook Inc.
Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.
Surgical Devices·38 affected·Oct 21, 2015
CriticalFDA
Cook Inc.
Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contras...
Surgical Devices·9,519 affected·Oct 7, 2015
CriticalFDA
Cook Inc.
Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the deli...
Surgical Devices·268,169 affected·Jul 2, 2015
CriticalFDA
Cook Inc.
Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast ...
Surgical Devices·248,167 affected·Jul 2, 2015
CriticalFDA
Cook Inc.
Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of c...
Surgical Devices·451,550 affected·Jul 2, 2015
High RiskFDA
Cook Inc.
Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular Intrahepatic Access Sets are intended for transjugular...
Surgical Devices·661 affected·May 28, 2015
High RiskFDA
Cook Inc.
LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior ...
Surgical Devices·123,184 affected·May 14, 2015
CriticalFDA
Cook Inc.
CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterilizable outer package and is supplied one pouch in...
Surgical Devices·696 affected·Jul 17, 2014
CriticalFDA
Cook, Inc.
Zilver¿ PTX¿ Drug-Eluting Peripheral Stent - 6 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral ...
Medical Implants·1,057 affected·Apr 18, 2013