Cook Inc.

Complete recall history across all FDA and CPSC categories — 262 total recalls

Cook Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (262)

FDA medical device enforcement actions by Cook Inc.. Showing most recent 50.

Date Product Reason Class
Nov 12, 2021 Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38... Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged... Class II
Nov 12, 2021 Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-... Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged... Class II
Oct 13, 2021 Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. R... Specific lots may contain black debris on the exterior of the inner stylet an... Class II
Oct 8, 2021 Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G0236... Transseptal needles may contain rust on the interior and/or exterior of the n... Class II
Oct 8, 2021 Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Co... Transseptal needles may contain rust on the interior and/or exterior of the n... Class II
Sep 28, 2021 Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G0990... Affected lots may be manufactured incorrectly with the radiopaque marker band... Class II
Sep 28, 2021 Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.... Affected lots may be manufactured incorrectly with the radiopaque marker band... Class II
Jan 4, 2021 Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for r... Manufactured with incorrect material, which may result in the stent being sti... Class II
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the p... Class I
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL1-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the p... Class I
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL1-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the p... Class I
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the p... Class I
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the p... Class I
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the p... Class I
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G4... There is an increased likelihood of the introducer sheath separating at the p... Class I
Nov 24, 2020 Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-6.0-38-90-R... There is an increased likelihood of the introducer sheath separating at the p... Class I
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the p... Class I
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the p... Class I
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the p... Class I
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the p... Class I
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the p... Class I
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G4... There is an increased likelihood of the introducer sheath separating at the p... Class I
Nov 24, 2020 Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-R... There is an increased likelihood of the introducer sheath separating at the p... Class I
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the p... Class I
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the p... Class I
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the p... Class I
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the p... Class I
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the p... Class I
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the p... Class I
Oct 22, 2020 Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved... Affected product was dropped during manufacturing, which may result in a bent... Class I
Aug 31, 2020 Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, ... The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pe... Class II
Aug 31, 2020 Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-... The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pe... Class II
Aug 11, 2020 Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated ... May contain excess glue within the handle of the delivery system, resulting i... Class II
Jul 30, 2020 Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Numb... Universa Soft Ureteral Stent Sets were incorrectly placed in the outer boxes ... Class II
Jun 2, 2020 Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usag... Identified products may contain a damaged bushing within the delivery system,... Class II
Apr 30, 2020 Pressure Monitoring Tray, C-PMSY, G02854 The Pressure Monitoring Set and Tray may contain excess coating material on t... Class II
Apr 30, 2020 Pressure Monitoring Set, C-PMS, G02838 The Pressure Monitoring Set and Tray may contain excess coating material on t... Class II
Apr 15, 2020 Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Numb... The firm received complaints on five devices from one specific lot where the ... Class II
Mar 6, 2020 Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-... The printed expiration dates are incorrect. Class II
Mar 6, 2020 Spectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Nu... The printed expiration dates are incorrect. Class II
Jan 16, 2020 Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is a... The firm has identified factors which contributed to failures relating to thr... Class II
Dec 27, 2019 Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3... Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured t... Class II
Nov 8, 2019 CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 ... A manufacturing error may cause the radiopaque marker bands to be too loose o... Class I
Nov 8, 2019 CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583... A manufacturing error may cause the radiopaque marker bands to be too loose o... Class I
Nov 8, 2019 CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577... A manufacturing error may cause the radiopaque marker bands to be too loose o... Class I
Nov 8, 2019 CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 ... A manufacturing error may cause the radiopaque marker bands to be too loose o... Class I
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed che... Class II
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed che... Class II
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed che... Class II
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed che... Class II

View all 262 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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