Cook, Inc.
Bloomington, IN
This page shows every FDA and USDA recall linked to Cook, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
564
Total Recalls
2002
First Recall
2021
Most Recent
Flexor Check-Flo Introducer Ansel Modification
Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC
Order Number/GPN:...
Nov 12, 2021
· Device
Terminated
Flexor Check-Flo Introducer Ansel Modification
Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC
Order Number/GPN: G...
Nov 12, 2021
· Device
Terminated
Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290.
Rigid needle available with EchoTi...
Oct 13, 2021
· Device
Open, Classified
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365.
Product consists of a tran...
Oct 8, 2021
· Device
Terminated
Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261.
Coaxial set consisting of an outer...
Oct 8, 2021
· Device
Terminated
Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908
The introducer sheath incorpor...
Sep 28, 2021
· Device
Terminated
Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069
The...
Sep 28, 2021
· Device
Terminated
Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extrac...
Jan 4, 2021
· Device
Terminated
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G56230
Flexor Introducers and G...
Dec 23, 2020
· Device
Terminated
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G56232
Flexor Introducers and G...
Dec 23, 2020
· Device
Terminated
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G56223
Flexor Introducers and G...
Dec 23, 2020
· Device
Terminated
Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-6.0-38-90-RB-SHTL-FLEX-HC, Order Number G311...
Dec 23, 2020
· Device
Terminated
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220
Flexor Introducers and G...
Dec 23, 2020
· Device
Terminated
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G56227
Flexor Introducers and G...
Dec 23, 2020
· Device
Terminated
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G56228
Flexor Introducers and G...
Dec 23, 2020
· Device
Terminated
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL1-HC, Order Number G56234
Flexor Introducers and G...
Dec 23, 2020
· Device
Terminated
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G56231
Flexor Introducers and G...
Dec 23, 2020
· Device
Terminated
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G56221
Flexor Introducers and G...
Dec 23, 2020
· Device
Terminated
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G49043
Flexor Introducers and G...
Dec 23, 2020
· Device
Terminated
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G56222
Flexor Introducers and G...
Dec 23, 2020
· Device
Terminated
Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-RB-SHTL-FLEX-HC, Order Number G311...
Dec 23, 2020
· Device
Terminated
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G56236
Flexor Introducers and G...
Dec 23, 2020
· Device
Terminated
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC, Order Number G56219
Flexor Introducers and G...
Dec 23, 2020
· Device
Terminated
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045
Flexor Introducers and G...
Dec 23, 2020
· Device
Terminated
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G56233
Flexor Introducers and G...
Dec 23, 2020
· Device
Terminated
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G56226
Flexor Introducers and G...
Dec 23, 2020
· Device
Terminated
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229
Flexor Introducers and G...
Dec 23, 2020
· Device
Terminated
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL1-HC, Order Number G56235
Flexor Introducers and G...
Dec 23, 2020
· Device
Terminated
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G56225
Flexor Introducers and G...
Dec 23, 2020
· Device
Terminated
Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating man...
Nov 3, 2020
· Device
Terminated
Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508. The set con...
Aug 31, 2020
· Device
Terminated
Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G150...
Aug 31, 2020
· Device
Terminated
Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only.
Indicated for the endovascular treatment of...
Aug 11, 2020
· Device
Terminated
Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used...
Jul 30, 2020
· Device
Terminated
Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is indicated for the endovasc...
Jun 2, 2020
· Device
Terminated
Pressure Monitoring Set, C-PMS, G02838
Jun 2, 2020
· Device
Terminated
Pressure Monitoring Tray, C-PMSY, G02854
Jun 2, 2020
· Device
Terminated
Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611
Balloon-expandab...
Apr 15, 2020
· Device
Terminated
Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G106...
Mar 6, 2020
· Device
Terminated
Spectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Number C-UDLMY-401 J-ABRM-HC-IHl-FS...
Mar 6, 2020
· Device
Terminated
Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.
Jan 31, 2020
· Device
Terminated
Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3-35-15-P-5S-CLDM-HC, UL T6. 3-35-...
Dec 27, 2019
· Device
Terminated
CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and intervent...
Dec 9, 2019
· Device
Terminated
CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and intervention...
Dec 9, 2019
· Device
Terminated
CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and intervent...
Dec 9, 2019
· Device
Terminated
CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventiona...
Dec 9, 2019
· Device
Terminated
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system...
Oct 21, 2019
· Device
Terminated
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system...
Oct 21, 2019
· Device
Terminated
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system...
Oct 21, 2019
· Device
Terminated
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system...
Oct 21, 2019
· Device
Terminated