Cook Inc.
188 recalls on record · Latest: Dec 29, 2021
FDA Devices Moderate Dec 29, 2021
Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of …
FDA Devices Moderate Dec 22, 2021
Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 Intended to introduce therapeuti…
FDA Devices Moderate Nov 24, 2021
Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and…
FDA Devices Moderate Nov 24, 2021
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
FDA Devices Moderate Nov 10, 2021
Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath incorporates a hydro…
FDA Devices Moderate Feb 17, 2021
Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.…
FDA Devices Critical Dec 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G56231 Flexor Introducers and Guiding Sheaths are intended to introduc…
FDA Devices Critical Dec 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G56233 Flexor Introducers and Guiding Sheaths are intended to introduc…
FDA Devices Critical Dec 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G56236 Flexor Introducers and Guiding Sheaths are intended to introduc…
FDA Devices Critical Dec 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220 Flexor Introducers and Guiding Sheaths are intended to introduc…
FDA Devices Critical Dec 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G56223 Flexor Introducers and Guiding Sheaths are intended to introduc…
FDA Devices Critical Dec 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229 Flexor Introducers and Guiding Sheaths are intended to introduc…
FDA Devices Critical Dec 30, 2020
Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-RB-SHTL-FLEX-HC, Order Number G31133 Flexor Introducers and Guiding S…
FDA Devices Critical Dec 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045 Flexor Introducers and Guiding Sheaths are intended to introduc…
FDA Devices Critical Dec 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G56227 Flexor Introducers and Guiding Sheaths are intended to introduc…
FDA Devices Critical Dec 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G56226 Flexor Introducers and Guiding Sheaths are intended to introduc…
FDA Devices Critical Dec 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G56221 Flexor Introducers and Guiding Sheaths are intended to introduc…
FDA Devices Critical Dec 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G56228 Flexor Introducers and Guiding Sheaths are intended to introduc…
FDA Devices Critical Dec 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G56232 Flexor Introducers and Guiding Sheaths are intended to introduc…
FDA Devices Critical Dec 30, 2020
Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-6.0-38-90-RB-SHTL-FLEX-HC, Order Number G31138 Flexor Introducers and Guiding S…
FDA Devices Critical Dec 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G49043 Flexor Introducers and Guiding Sheaths are intended to introduc…
FDA Devices Critical Dec 30, 2020
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G56225 Flexor Introducers and Guiding Sheaths are intended to introduc…
FDA Devices Critical Nov 11, 2020
Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To ass…
FDA Devices Moderate Sep 23, 2020
Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aort…
FDA Devices Moderate Jun 10, 2020
Pressure Monitoring Set, C-PMS, G02838
FDA Devices Moderate Mar 4, 2020
Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.
FDA Devices Moderate Feb 12, 2020
Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G49867 G49868 G49869 G49870 G49874 G49875 G49877 G49879 G49881 G498…
FDA Devices Moderate Feb 12, 2020
PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10
FDA Devices Moderate Feb 12, 2020
Angled Tip Ureteral Catheter Set with Bentson PTFE Wire Guide, Ureteral Catheter, Global Product No. G19108 G14587 G15302 G14326
FDA Devices Moderate Feb 12, 2020
Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823
FDA Devices Moderate Feb 12, 2020
Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844
FDA Devices Moderate Feb 12, 2020
Percutaneous Entry Set, Nephrostomy Catheter, Global Product No. G14649
FDA Devices Moderate Feb 12, 2020
Sof-Flex Double Pigtail Ureteral Stent Set, Global Product No. G15076 G14906 G14840 G14865 G17128
FDA Devices Moderate Feb 12, 2020
Kwart Retro-Inject Ureteral Stent Set, Global Product No. G15016 G14836 G14885 G14887 G17151
FDA Devices Moderate Feb 12, 2020
Wire Guide, Guidewire, Global Product Number G14326
FDA Devices Moderate Feb 12, 2020
Urethral Dilator Set, Global Product No. G14185
FDA Devices Moderate Feb 12, 2020
Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866
FDA Devices Moderate Feb 12, 2020
Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590
FDA Devices Moderate Feb 12, 2020
Angled Tip Ureteral Catheter Set, Ureteral Catheter, Global Product No. G14598
FDA Devices Moderate Feb 12, 2020
Heavy Duty PTFE Wire Guide, Guidewire, Global Product Number G14323 G14260 G14260
FDA Devices Moderate Feb 12, 2020
C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 G14367
FDA Devices Moderate Feb 12, 2020
Percutaneous Malecot Nephrostomy Set, Global Product No. G16714 G19107 G19108
FDA Devices Moderate Feb 12, 2020
Percutaneous Pigtail Nephrostomy Set , Global Product No. G14094 G14095 G14899 G14329
FDA Devices Moderate Feb 12, 2020
Universa Soft Ureteral Stent, Global Product No. G49887 G49933 G49934 G49937 G49940 G49941 G49942 G49945 G49947 G49948 G49949 G49950 G499…
FDA Devices Moderate Jan 22, 2020
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 T7.0-35-25-P-5S-CLD…
FDA Devices Critical Dec 18, 2019
CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular procedures.
FDA Devices Critical Dec 18, 2019
CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures.
FDA Devices Critical Dec 18, 2019
CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures.
FDA Devices Critical Dec 18, 2019
CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventional vascular procedures.
FDA Devices Moderate Nov 27, 2019