PlainRecalls

Cook Inc.

264 recalls on record · Latest: Dec 29, 2021

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Agency notice ledger

Federal filing book Cook Inc. HEAVY-BOOK · SINGLE-AGENCY

#44 of 14,151 · 264 notices · 0.253% archive

  • BOOK 264 notices
  • RANK #44 of 14,151
  • SHARE 0.253% archive
  • AGENCY FDA Devices (264)
  • CAT medical devices
  • CATS 1 category
  • LATEST Dec 29, 2021
  • PHOTO Honda

Nearest notice-volume peer: Honda (1 notice gap)

Cook Inc. accounts for about 0.253% of the 104,423-notice archive on 264 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Where Cook Inc. sits among 14,151 recalling firms

Cook Inc. ranks 44th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Cook Inc. vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

264 44th of 14151 higher than 14,107 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Cook Inc. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Cook Inc. holds about 0.253% of archive notices alongside 264 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate May 29, 2019

Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168 4.0 Fr - SIPSF-040018-59 G32773 4.7 Fr SIPSF-050018-59 G32774

FDA Devices Critical Mar 20, 2019

Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.

FDA Devices Moderate Mar 6, 2019

Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, Order Number G35570 The Entuit Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to the introduction of interventional catheters.

FDA Devices Moderate Mar 6, 2019

Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2, Order Number G35569 The Entuit Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to the introduction of interventional catheters.

FDA Devices Moderate Feb 27, 2019

Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571

FDA Devices Moderate Aug 22, 2018

VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Product Usage: The VentriClear Ventricular Drainage Catheter Set has been designed for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of relieving elevated intracranial pressure or fluid volume.

FDA Devices Moderate May 16, 2018

Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM-BNS Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.

FDA Devices Moderate May 16, 2018

Connecting Tube - Female to Male Luer Lock, HPCT8.8-100-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.

FDA Devices Moderate May 16, 2018

Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.

FDA Devices Moderate May 16, 2018

Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.

FDA Devices Moderate May 16, 2018

Connecting Tube - Female to Male Luer Lock, HPCT8.8-30-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.

FDA Devices Moderate May 16, 2018

Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.

FDA Devices Moderate May 9, 2018

StoneBreaker Exhaust Cap, Catalog number: SBA-EC; GPN: G52599; UDI: (01)00827002525993

FDA Devices Moderate May 9, 2018

StoneBreaker Single Use Probe, Catalog numbers: SBP-010500; SBP-010605; SBP-016500; SBP-016605; SBP-020425 GPN : G52607; G52605; G52606; G52609; G52608

FDA Devices Moderate May 9, 2018

StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020

FDA Devices Moderate May 9, 2018

StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044

FDA Devices Moderate May 9, 2018

StoneBreaker C02 Cartridge, Catalog number: SBC-10; GPN: G52603; UDI: (01)10827002526034

FDA Devices Moderate May 9, 2018

StoneBreaker Probe Cap, Catalog number:SBA-PC; GPN: G52601; UDI:(01)00827002526013

FDA Devices Moderate May 9, 2018

StoneBreaker Exhaust Line, Catalog number: SBA-EL; GPN: G52600; UDI: (01)00827002526006

FDA Devices Moderate May 2, 2018

Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: PTA5-35-135-6-2 .0 and PTA5-35-135-4-4 .0; UDI: 10827002522647 and 10827002522524 Product Usage: The Advance¿ 35LP Low Profile PTA Balloon Dilation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

FDA Devices Moderate Apr 25, 2018

Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intended for the aspiration of body fluids and cells, in particular oocyte aspiration.

FDA Devices Moderate Apr 25, 2018

MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000) G20079 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture.

FDA Devices Moderate Apr 25, 2018

MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000 US) G46022 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture.

FDA Devices Moderate Apr 25, 2018

Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607. Intended for the aspiration of body fluids and cells; in particular oocyte aspiration.

FDA Devices Moderate Apr 4, 2018

Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use

FDA Devices Moderate Apr 4, 2018

Echosight Jansen-Anderson Intratubal Transfer Set, Catalog Number: K-J-JITS-572900, Global Product Number: G17946 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use

FDA Devices Moderate Apr 4, 2018

1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number: G19182; 2. Guardia" Access Nano Embryo Transfer Catheter, Catalog Number: K-JETS-551910-L, Global Product Number: G24215; 3. Sydney IVF¿ Embryo Transfer Set, Product Number: K-JETS-7019-SIVF, Global Product Number: G18740

FDA Devices Moderate Apr 4, 2018

Marrs Laparoscopic GIFT Catheters, Catalog Number:K-J-MLC-503000, Global Product Number: G18022 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use

FDA Devices Moderate Mar 21, 2018

Coons Interventional Wire Guide

FDA Devices Moderate Mar 21, 2018

Movable Core Wire Guide

FDA Devices Moderate Mar 21, 2018

Amplatz Extra Stiff Wire Guide

FDA Devices Moderate Mar 21, 2018

Amplatz Ultra Stiff Wire Guide

FDA Devices Moderate Mar 21, 2018

Bentson Cerebral Wire Guide

FDA Devices Moderate Mar 21, 2018

Femoral Artery Pressure Monitoring Set

FDA Devices Moderate Mar 21, 2018

Reuter Tip Deflecting Wire Guide

FDA Devices Moderate Mar 21, 2018

Amplatz Stiff Wire Guide

FDA Devices Moderate Mar 21, 2018

Double Flexible Tipped Wire Guide

FDA Devices Moderate Mar 21, 2018

Left Atrial Catheter Set

FDA Devices Moderate Mar 21, 2018

Bentson Wire Guide

FDA Devices Moderate Mar 21, 2018

Amplatz Extra Stiff Whisker Wire Guide

FDA Devices Moderate Mar 21, 2018

Central Venous Catheter Tray

FDA Devices Moderate Mar 21, 2018

Fixed Core Wire Guide

FDA Devices Moderate Mar 21, 2018

Bentson Plus Wire Guide

FDA Devices Moderate Mar 21, 2018

Disposable Reuter Tip Deflecting Wire Guide

FDA Devices Moderate Mar 21, 2018

Fixed Core Bentson

FDA Devices Moderate Mar 21, 2018

TFE Coated Curved Newton LLT

FDA Devices Moderate Mar 21, 2018

Rosen Curved Wire Guide

FDA Devices Moderate Mar 21, 2018

Newton Wire Guide

FDA Devices Moderate Mar 7, 2018

Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding

FDA Devices Moderate Mar 7, 2018

Percutaneous Gastrojejunostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding

Cook Inc. carries an outsized archive share

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (264 here — heavy-book).

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Frequently Asked Questions

How many federal recall notices name Cook Inc.?
PlainRecalls indexes 264 distinct federal recall events naming Cook Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Cook Inc. sit among other recalling firms?
Cook Inc. ranks #44 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Cook Inc.'s notices?
FDA Devices accounts for 264 of this firm's 264 indexed notices.
What product category dominates Cook Inc.'s filing book?
Filings for Cook Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous?
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Cook Inc.: 264 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Cook Inc.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026