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 1 critical, 49 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 Mar 7, 2018 to Nov 27, 2019.

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 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…

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…

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…

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…

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…

FDA Devices Moderate Jun 19, 2019

Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT

FDA Devices Moderate Jun 12, 2019

Thoracentesis Set, RPN C-THS-850, Order # G03286

FDA Devices Moderate Jun 12, 2019

Pericardiocentesis Catheter Tray, RPN C-PCSY-850-LHSC-061096, Order # G10030

FDA Devices Moderate Jun 12, 2019

Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282

FDA Devices Moderate Jun 12, 2019

Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284

FDA Devices Moderate May 29, 2019

Cook Kwart Retro-Inject Ureteral Stent Set: PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr 003500 G14916; 6.0 Fr 003600 G14836; 7.0 Fr 003700 G1483…

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 …

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…

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 …

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 …

FDA Devices Moderate Feb 27, 2019

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

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 re…

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 reser…

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 reserv…

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 reserv…

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; G52…

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 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 10827…

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 asp…

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…

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) em…

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 …

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 …

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 fertilize…

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 7, 2018

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

FDA Devices Moderate Mar 7, 2018

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

FDA Devices Moderate Mar 7, 2018

Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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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