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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.
Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 Intended to introduc...
Diagnostic Devices·47 affected·Nov 12, 2021
High RiskFDA
Cook Inc.
Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visua...
Medical Devices·112 affected·Oct 13, 2021
CriticalFDA
Cook Inc.
Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal ...
Surgical Devices·4,789 affected·Oct 8, 2021
CriticalFDA
Cook Inc.
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
Medical Devices·31,502 affected·Oct 8, 2021
High RiskFDA
Cook Inc.
Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath incorpor...
Medical Devices·48 affected·Sep 28, 2021
High RiskFDA
Cook Inc.
Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotr...
Medical Implants·42 affected·Jan 4, 2021
CriticalFDA
Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G56231 Flexor Introducers and Guiding Sheaths are intended...
Diagnostic Devices·9,768 affected·Nov 24, 2020
CriticalFDA
Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G56233 Flexor Introducers and Guiding Sheaths are intended...
Diagnostic Devices·228 affected·Nov 24, 2020
CriticalFDA
Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G56236 Flexor Introducers and Guiding Sheaths are intended...
Diagnostic Devices·8,362 affected·Nov 24, 2020
CriticalFDA
Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220 Flexor Introducers and Guiding Sheaths are intended...
Diagnostic Devices·2,807 affected·Nov 24, 2020
CriticalFDA
Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G56223 Flexor Introducers and Guiding Sheaths are intended...
Diagnostic Devices·228 affected·Nov 24, 2020
CriticalFDA
Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229 Flexor Introducers and Guiding Sheaths are intended...
Diagnostic Devices·611 affected·Nov 24, 2020
CriticalFDA
Cook Inc.
Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-RB-SHTL-FLEX-HC, Order Number G31133 Flexor Introducers a...
Diagnostic Devices·902 affected·Nov 24, 2020
CriticalFDA
Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045 Flexor Introducers and Guiding Sheaths are intended...
Diagnostic Devices·1,527 affected·Nov 24, 2020
CriticalFDA
Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G56227 Flexor Introducers and Guiding Sheaths are intended...
Diagnostic Devices·1,152 affected·Nov 24, 2020
CriticalFDA
Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G56226 Flexor Introducers and Guiding Sheaths are intended...
Diagnostic Devices·1,780 affected·Nov 24, 2020
CriticalFDA
Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G56221 Flexor Introducers and Guiding Sheaths are intended...
Diagnostic Devices·4,408 affected·Nov 24, 2020
CriticalFDA
Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G56228 Flexor Introducers and Guiding Sheaths are intended...
Diagnostic Devices·631 affected·Nov 24, 2020
CriticalFDA
Cook Inc.
Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless st...
Surgical Devices·61 affected·Oct 22, 2020
High RiskFDA
Cook Inc.
Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal ao...
Medical Devices·684 affected·Aug 11, 2020
High RiskFDA
Cook Inc.
Pressure Monitoring Set, C-PMS, G02838
Medical Devices·6,792 affected·Apr 30, 2020
High RiskFDA
Cook Inc.
Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3-35-15-P-5S-CLDM-HC, UL T6. 3-35-25-P-58-CLDM-HC, UL T7.0-35...
Surgical Devices·1,604 affected·Dec 27, 2019
CriticalFDA
Cook Inc.
CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular procedures.
Surgical Devices·6 affected·Nov 8, 2019
CriticalFDA
Cook Inc.
CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures.
Surgical Devices·58 affected·Nov 8, 2019
CriticalFDA
Cook Inc.
CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures.
Surgical Devices·43 affected·Nov 8, 2019
CriticalFDA
Cook Inc.
CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventional vascular procedures.
Surgical Devices·20 affected·Nov 8, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·30 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·10 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·5 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·10 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·30 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·5 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·425 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·5 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·145 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·80 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·791 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·740 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·35 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·1,679 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·405 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·95 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·5 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·20 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·311 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·10 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·20 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·100 affected·Oct 21, 2019