PlainRecalls

Cook Inc.

188 recalls on record · Latest: Dec 29, 2021

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