Wilson-Cook Medical Inc.

Disposable Hemostasis Clip, DCH-7-230, Rx only, Single Use only, Cook Medical Product Usage: This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal sub-mucosal defects less thank 3cm in the upper GI tract, bleeding ulcers, arteries les than 2 mm, and polyps less than 1.5cm in diameter in the GI tract,. This device is not intended for the repair of GI tract luminal perforations.

FDA Recall

Terminated ·Cook Endoscopy·Product code MND·June 7, 2011

Brodmerkel Colon Decompression Set, CDSB-10, Catheter Diameter: 10 Fr. Catheter Length: 350 cm. Sideports: 10, Standard wire Guide: .035''/480 cm. Disposable Single use only, Rx Only. Cook, Wilson-Cook Medicl GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.

FDA Recall

Terminated ·Wilson-Cook Medical Inc·Product code FEG·October 8, 2003

EUSN-19-QC Quick-Core Ultrasound Biopsy Needle, Specimen Notch: 20 MM.; Diameter: 5.2 FR. Tapered to 4.5FR. Length: 138-140 CM. Adjustable Needle: 19 GA. Needle Extension: 0-8 CM. Adjustable Minimum Endoscope Channel: 2.0 MM. Disposable-Single Use Only Sterile Shelf Life: 5 Years, Wilson Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston Salem, NC 27105.

FDA Recall

Terminated ·Wilson-Cook Medical Inc·Product code FCG·April 23, 2002

Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies.

FDA Recall

Open, Classified ·Wilson-Cook Medical Inc.·Product code FFL·June 22, 2023

Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663;

FDA Recall

Open, Classified ·Wilson-Cook Medical Inc.·Product code QAU·May 22, 2023

Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346

FDA Recall

Open, Classified ·Wilson-Cook Medical Inc.·Product code QAU·May 22, 2023

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree

FDA Recall

Open, Classified ·Wilson-Cook Medical Inc.·Product code FGE·November 3, 2023

COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S

FDA Recall

Terminated ·Wilson-Cook Medical Inc.·Product code FFF·December 18, 2018

COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S

FDA Recall

Terminated ·Wilson-Cook Medical Inc.·Product code FFF·December 18, 2018

Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.

FDA Recall

Terminated ·Wilson-Cook Medical Inc.·Product code KNS·January 4, 2019

ESD-5, ESD Flexible Endoscopic Suturing Device, Flexible Sew Right Device: Flexible TI Knot Device: External Accessory Channel: 6mm./75 cm.; * Suture Quickload Units (2); TI Knot Quickload Units (2) * Disposable Single Use Only * Manufactured by: LSI Solutions * Sterile/EO * Rx Only * Wilson-Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.

FDA Recall

Terminated ·Wilson-Cook Medical Inc·Product code GCJ·April 1, 2005

Za-Stent Expandable Metal Biliary Stent

FDA Recall

Terminated ·Wilson-Cook Medical Inc·Product code FGE·January 8, 2002

Nasal Jejunal Feeding Tube, Tube Diameter: 10 FR. Tube Length: 240CM., Disposable Single Use Only, Rx Only***COOK Wilson Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105

FDA Recall

Terminated ·Wilson-Cook Medical Inc·Product code FPD·May 26, 2004

APSOF-7-4-RB, ZIMMON PANCREATIC STENT W/RADIOPAQUE BANDS, Stent Diameter: 7 FR., Length (Between Curl and Flap): 4 CM, For Use With Wilson-Cook Stent Introduction System: 7 FR. Minimum Accessory Channel Size: 2.8 MM., Disposable-Single Use Only, Rx Only, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105

FDA Recall

Terminated ·Wilson-Cook Medical Inc·Product code FGE·July 25, 2003

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree

FDA Recall

Open, Classified ·Wilson-Cook Medical Inc.·Product code FGE·November 3, 2023

Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO

FDA Recall

Open, Classified ·Wilson-Cook Medical Inc.·Product code PKL·March 3, 2026

Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These devices are used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. It is indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts.

FDA Recall

Open, Classified ·Wilson-Cook Medical Inc.·Product code KNS·December 18, 2025

Oasis-One Action Stent Introduction System with ST-2 Soehendra Tannenbaum Biliary Stent, (11.5 French size only), Guiding Catheter: 6 FR, Minimum Accessory Channel Size: 3.7mm, Wire Guide Sold Separately, Disposable Single Use Only, Quality System ISO 9001 Certified, Rx Only, Wilson-Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105

FDA Recall

Terminated ·Wilson-Cook Medical Inc·Product code FGE·December 22, 2003

Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.

FDA Recall

Open, Classified ·Wilson-Cook Medical Inc.·Product code QAU·October 31, 2024

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree

FDA Recall

Open, Classified ·Wilson-Cook Medical Inc.·Product code FGE·November 3, 2023