PlainRecalls

Cook Inc.

188 recalls on record · Latest: Dec 29, 2021

Cook Inc. Recall Insight

Cook Inc. appears on 188 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.224% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Dec 29, 2021, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 21 critical, 29 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Nov 27, 2019 to Dec 29, 2021.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

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

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in gi…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Cook Inc. with FORD →

Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds