Cook Inc. recalls

261 recalls on record · latest: November 12, 2021

Official U.S. recall history for Cook Inc., compiled from official government records.

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Flexor Check-Flo Introducer Ansel Modification recalled over labeling errors

November 12, 2021 · Medical device recalls Moderate risk Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged wi…

Flexor Check-Flo Introducer Ansel Modification recalled over labeling errors

November 12, 2021 · Medical device recalls Moderate risk Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged wi…

Cook Inc. recalls Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide…

October 13, 2021 · Medical device recalls Moderate risk Specific lots may contain black debris on the exterior of the inner stylet and/…

Cook Inc. recalls Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curv…

October 8, 2021 · Medical device recalls Moderate risk Transseptal needles may contain rust on the interior and/or exterior of the nee…

Cook Inc. recalls Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needl…

October 8, 2021 · Medical device recalls Moderate risk Transseptal needles may contain rust on the interior and/or exterior of the nee…

Cook Inc. recalls Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introduce…

September 28, 2021 · Medical device recalls Moderate risk Affected lots may be manufactured incorrectly with the radiopaque marker band l…

Cook Inc. recalls Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The introducer sheath incorporates a hyd…

September 28, 2021 · Medical device recalls Moderate risk Affected lots may be manufactured incorrectly with the radiopaque marker band l…

Cook Inc. recalls Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal…

January 4, 2021 · Medical device recalls Moderate risk Manufactured with incorrect material, which may result in the stent being stiff…

Cook Inc. recalls Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G56231 Flexor Introducers and Guiding Sheath…

November 24, 2020 · Medical device recalls High risk There is an increased likelihood of the introducer sheath separating at the pro…

Cook Inc. recalls Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G56233 Flexor Introducers and Guiding Sheath…

November 24, 2020 · Medical device recalls High risk There is an increased likelihood of the introducer sheath separating at the pro…

Cook Inc. recalls Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G56236 Flexor Introducers and Guiding Sheath…

November 24, 2020 · Medical device recalls High risk There is an increased likelihood of the introducer sheath separating at the pro…

Cook Inc. recalls Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220 Flexor Introducers and Guiding Sheath…

November 24, 2020 · Medical device recalls High risk There is an increased likelihood of the introducer sheath separating at the pro…

Cook Inc. recalls Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G56223 Flexor Introducers and Guiding Sheath…

November 24, 2020 · Medical device recalls High risk There is an increased likelihood of the introducer sheath separating at the pro…

Cook Inc. recalls Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229 Flexor Introducers and Guiding Sheath…

November 24, 2020 · Medical device recalls High risk There is an increased likelihood of the introducer sheath separating at the pro…

Cook Inc. recalls Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-RB-SHTL-FLEX-HC, Order Number G31133 Flexor…

November 24, 2020 · Medical device recalls High risk There is an increased likelihood of the introducer sheath separating at the pro…

Cook Inc. recalls Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045 Flexor Introducers and Guiding Sheath…

November 24, 2020 · Medical device recalls High risk There is an increased likelihood of the introducer sheath separating at the pro…

Cook Inc. recalls Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G56227 Flexor Introducers and Guiding Sheath…

November 24, 2020 · Medical device recalls High risk There is an increased likelihood of the introducer sheath separating at the pro…

Cook Inc. recalls Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G56226 Flexor Introducers and Guiding Sheath…

November 24, 2020 · Medical device recalls High risk There is an increased likelihood of the introducer sheath separating at the pro…

Cook Inc. recalls Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G56221 Flexor Introducers and Guiding Sheath…

November 24, 2020 · Medical device recalls High risk There is an increased likelihood of the introducer sheath separating at the pro…

Cook Inc. recalls Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G56228 Flexor Introducers and Guiding Sheath…

November 24, 2020 · Medical device recalls High risk There is an increased likelihood of the introducer sheath separating at the pro…

Cook Inc. recalls Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G56232 Flexor Introducers and Guiding Sheath…

November 24, 2020 · Medical device recalls High risk There is an increased likelihood of the introducer sheath separating at the pro…

Cook Inc. recalls Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-6.0-38-90-RB-SHTL-FLEX-HC, Order Number G31138 Flexor…

November 24, 2020 · Medical device recalls High risk There is an increased likelihood of the introducer sheath separating at the pro…

Cook Inc. recalls Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G49043 Flexor Introducers and Guiding Sheath…

November 24, 2020 · Medical device recalls High risk There is an increased likelihood of the introducer sheath separating at the pro…

Cook Inc. recalls Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G56225 Flexor Introducers and Guiding Sheath…

November 24, 2020 · Medical device recalls High risk There is an increased likelihood of the introducer sheath separating at the pro…

Cook Inc. recalls Flexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC, Order Number G56219 Flexor Introducers and Guiding Sheath…

November 24, 2020 · Medical device recalls High risk There is an increased likelihood of the introducer sheath separating at the pro…

Cook Inc. recalls Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G56222 Flexor Introducers and Guiding Sheath…

November 24, 2020 · Medical device recalls High risk There is an increased likelihood of the introducer sheath separating at the pro…

Cook Inc. recalls Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL1-HC, Order Number G56235 Flexor Introducers and Guiding Sheath…

November 24, 2020 · Medical device recalls High risk There is an increased likelihood of the introducer sheath separating at the pro…

Cook Inc. recalls Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL1-HC, Order Number G56234 Flexor Introducers and Guiding Sheath…

November 24, 2020 · Medical device recalls High risk There is an increased likelihood of the introducer sheath separating at the pro…

Cook Inc. recalls Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G56230 Flexor Introducers and Guiding Sheath…

November 24, 2020 · Medical device recalls High risk There is an increased likelihood of the introducer sheath separating at the pro…

Fixed Core Wire Guide recalled over foreign material

October 22, 2020 · Medical device recalls High risk Affected product was dropped during manufacturing, which may result in a bent w…

Cook Inc. recalls Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G15035. The s…

August 31, 2020 · Medical device recalls Moderate risk The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pedi…

Cook Inc. recalls Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508. The set contains a 22…

August 31, 2020 · Medical device recalls Moderate risk The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pedi…

Cook Inc. recalls Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients…

August 11, 2020 · Medical device recalls Moderate risk May contain excess glue within the handle of the delivery system, resulting in…

Cook Inc. recalls Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for temp…

July 30, 2020 · Medical device recalls Moderate risk Universa Soft Ureteral Stent Sets were incorrectly placed in the outer boxes la…

Cook Inc. recalls Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is indicated for the endovascular treat…

June 2, 2020 · Medical device recalls Moderate risk Identified products may contain a damaged bushing within the delivery system, w…

Cook Inc. recalls Pressure Monitoring Set, C-PMS, G02838

April 30, 2020 · Medical device recalls Moderate risk The Pressure Monitoring Set and Tray may contain excess coating material on the…

Cook Inc. recalls Pressure Monitoring Tray, C-PMSY, G02854

April 30, 2020 · Medical device recalls Moderate risk The Pressure Monitoring Set and Tray may contain excess coating material on the…

Cook Inc. recalls Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611 Balloon-expandable stent m…

April 15, 2020 · Medical device recalls Moderate risk The firm received complaints on five devices from one specific lot where the st…

Cook Inc. recalls Spectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Number C-UDLMY-401 J-ABRM-HC-IHl-FST, Order…

March 6, 2020 · Medical device recalls Moderate risk The printed expiration dates are incorrect.

Cook Inc. recalls Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643

March 6, 2020 · Medical device recalls Moderate risk The printed expiration dates are incorrect.

Cook Inc. recalls Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.

January 16, 2020 · Medical device recalls Moderate risk The firm has identified factors which contributed to failures relating to throm…

Cook Inc. recalls Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3-35-15-P-5S-CLDM-HC, UL T6. 3-35-25-P-58-C…

December 27, 2019 · Medical device recalls Moderate risk Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured to…

Cook Inc. recalls CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular…

November 8, 2019 · Medical device recalls High risk A manufacturing error may cause the radiopaque marker bands to be too loose on…

Cook Inc. recalls CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascula…

November 8, 2019 · Medical device recalls High risk A manufacturing error may cause the radiopaque marker bands to be too loose on…

Cook Inc. recalls CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascula…

November 8, 2019 · Medical device recalls High risk A manufacturing error may cause the radiopaque marker bands to be too loose on…

Cook Inc. recalls CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventional vascular…

November 8, 2019 · Medical device recalls High risk A manufacturing error may cause the radiopaque marker bands to be too loose on…