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 |
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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