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Wilson-Cook Medical, Inc.

United States·US-MF-000002658

Last updated September 18, 2026

About

Cook Medical is a family-owned medical device company that works with physicians to develop devices that are less invasive for patients.

From the manufacturer's own website. Source

Information

Country: United States
Address: 4900, Bethania Station Road, Winston-Salem, United States
Website: www.cookmedical.com
LinkedIn: linkedin.com/company/cookmedical
Facebook: facebook.com/CookMedical
Email: [email protected]
Phone: 01-336-744-0157
PRRC Contact: Benjamin Nickless
EUDAMED SRN: US-MF-000002658
FDA FEI Number: —
DUNS Number: —

Catalogue (258)

Page 1 of 6

Device	Model / Reference	Registries	Class	Status
Wire Guided Balloon Dilator	ECL-16X5.5	EUDAMEDFDA UDI	Class I	Active
Esophageal Balloon Dilator	QD-20X8	EUDAMEDFDA UDI	Class I	Active
Hercules 3 Stage Balloon Esophageal	HBD-18-19-20	EUDAMEDFDA UDI	Class I	Active
Soehendra Stent Retriever	SSR-5	EUDAMEDFDA UDI	Class I	Active
Colonic Balloon Dilator	QDC-16X5.5	EUDAMEDFDA UDI	Class I	Active
Disposable Varices Injector	LDVI-23-MH	EUDAMEDFDA UDI	Class IIa	Active
Bronchoscope Cytology Brush	BCB-5-120-2-S	EUDAMEDFDA UDI	Class I	Active
Acrobat 2 Calibrated Tip Wire Guide	AWG2-35-450	EUDAMEDFDA UDI	Class I	Active
Acusnare Polypectomy Snare Soft	SASH-1-S	EUDAMEDFDA UDI	Class IIb	Active
Disposable Varices Injector	LDVI-25-MH	EUDAMEDFDA UDI	Class IIa	Active
Fusion Extraction Balloon with Multiple Sizing	FS-8.5-12-15-B	EUDAMEDFDA UDI	Class I	Active
Hercules 3 Stage WireGuided Balloon Esophageal-Pyloric Colonic	HBD-W-10-11-12	EUDAMEDFDA UDI	Class I	Active
Wire Guided Balloon Dilator	ECL-10X5.5	EUDAMEDFDA UDI	Class I	Active
Fusion Quattro Extraction Balloon	FS-QEB-B	EUDAMEDFDA UDI	Class I	Active
Pvl-4.8-200 Balloon Stone Extractor	K851954	FDA 510(k)	Class II	Active
Wilson-Cook Balloon Inflation Device	K933845	FDA 510(k)	Class II	Active
Gastrointestinal Feeding Tube	K920703	FDA 510(k)	Class II	Active
Wilson-Cook Gianturco-Rosch Biliary Z Stent	K896069	FDA 510(k)	Class II	Active
Wilson-Cook Mini Basket	K182381	FDA 510(k)	Class II	Active
Wilson-Cook Thru-The-Scope Mechanical Lithotriptor	K011178	FDA 510(k)	Class II	Active
Howell Biliary Introducer Needle	K160890	FDA 510(k)	Class II	Active
AcuSnare Polypectomy Snare - Duckbill	K191048	FDA 510(k)	Class II	Active
Wilson-Cook Cytology Brushes	K896318	FDA 510(k)	Class II	Active
Wilson-Cook Biliary Motility Catheter	K900058	FDA 510(k)	Class II	Active
Tracer Metro Smart Wire Guide	K033754	FDA 510(k)	Class II	Active
Wilson-Cook Reusable Hot Biopsy Forceps	K000086	FDA 510(k)	Class II	Active
Esophageal Z-Stent With Dua Anti-Reflux Valve	K011591	FDA 510(k)	Class II	Active
Lehman Manometry Catheter	K160170	FDA 510(k)	Class II	Active
Entuit Nasal Jejunal Feeding Tube	K201322	FDA 510(k)	Class II	Active
Sullivan Variable Stiffness Cable	K901610	FDA 510(k)	Class II	Active
Wilson-Cook Triple Lumen Balloon Stone Extractor	K953951	FDA 510(k)	Class II	Active
Entuit PEG, Entuit PEGJ	K183336	FDA 510(k)	Class II	Active
Low Profile Passport Push & Pull Kits & Peg Tube	K920579	FDA 510(k)	Class II	Active
Entuit PEG, Entuit PEGJ	K213356	FDA 510(k)	Class II	Active
Wilson-Cook Double Lumen Biliary Cytology Brush	K040324	FDA 510(k)	Class II	Active
Disposable Bronchoscope Biopsy Forceps	K923847	FDA 510(k)	Class II	Active
Wilson-Cook Stricture Measuring Catheter	K973205	FDA 510(k)	Class II	Active
Disposable Hot Biopsy Forceps	K923470	FDA 510(k)	Class II	Active
Modification To Wilson-Cook Multiple Band Ligator	K020526	FDA 510(k)	Class II	Active
Savary-Gilliard Dilator	K851955	FDA 510(k)	Class II	Active
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush	K171573	FDA 510(k)	Class II	Active
SureTome™ SW Sphincterotome with DomeTip	K251104	FDA 510(k)	Class II	Active
Howell Biliary Aspiration Needle	K153763	FDA 510(k)	Class II	Active
Axcess Soft Tip Wire Guide	K122816	FDA 510(k)	Class II	Active
Wilson-Cook Retrieval & Grasping Forceps	K902400	FDA 510(k)	Class II	Active
Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter	K171548	FDA 510(k)	Class II	Active
Usw Needleknife Papillotome	K040981	FDA 510(k)	Class II	Active
Chiba Needle	K851957	FDA 510(k)	Class I	Active
Balloon Dilation Catheter	K935094	FDA 510(k)	Class II	Active
Accessory Irrigation Adapter	K162142	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

Cook Medical Europe Limited IE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (44)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 3, 2026	Z-1812-2026	—	open, classified	Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.
Dec 18, 2025	Z-1362-2026	—	open, classified	Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.
Dec 15, 2025	Z-1298-2026	—	open, classified	Nasal feeding tube packaged without the nasal transfer tube component.
Oct 31, 2024	Z-0582-2025	—	open, classified	Specific lots of product have been manufactured with nonconforming raw materials resulting in the red activation knob cracking or breaking at the activation knob internal threading while the device is activated.
Aug 29, 2024	Z-0036-2025	—	open, classified	Specific lots of product have been manufactured with nonconforming raw materials.
Nov 3, 2023	Z-0457-2024	—	open, classified	Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
Nov 3, 2023	Z-0461-2024	—	open, classified	Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
Nov 3, 2023	Z-0463-2024	—	open, classified	Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
Nov 3, 2023	Z-0460-2024	—	open, classified	Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
Nov 3, 2023	Z-0458-2024	—	open, classified	Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
Nov 3, 2023	Z-0462-2024	—	open, classified	Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
Nov 3, 2023	Z-0459-2024	—	open, classified	Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
Jun 22, 2023	Z-2253-2023	—	open, classified	Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or without mechanical lithotripsy).
Jun 22, 2023	Z-2252-2023	—	open, classified	Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or without mechanical lithotripsy).
May 22, 2023	Z-1979-2023	—	open, classified	There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope.
May 22, 2023	Z-1978-2023	—	open, classified	There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope.
Feb 4, 2020	Z-1746-2020	—	terminated	Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the carbon dioxide cartridge to exit the handle. Most of these complaints reported that the carbon dioxide cartridge exited the handle with minimal force. However, some complaints reported that the carbon dioxide cartridge exited the handle with the potential to project towards a user or a patient.
Feb 4, 2020	Z-1745-2020	—	terminated	Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the carbon dioxide cartridge to exit the handle. Most of these complaints reported that the carbon dioxide cartridge exited the handle with minimal force. However, some complaints reported that the carbon dioxide cartridge exited the handle with the potential to project towards a user or a patient.
Jul 24, 2019	Z-2541-2019	—	terminated	Potential for Hemospray device to be unable to spray powder due to misassembly of devices.
Jun 14, 2019	Z-2089-2019	—	terminated	Potential for occluded injection needles.
Jan 4, 2019	Z-1132-2019	—	terminated	Complaints of the snare loop not completely retracting and/or misshaping of the snare loop.
Dec 18, 2018	Z-0774-2019	—	terminated	The product is being recalled because Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S) were mislabeled as Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) and Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) were mislabeled as Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S).
Dec 18, 2018	Z-0775-2019	—	terminated	The product is being recalled because Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S) were mislabeled as Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) and Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) were mislabeled as Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S).
Oct 31, 2005	Z-0270-06	—	terminated	Misbranded; The catheter size listed on the product label is 6 French, which is inaccurate. The catheter size is more accurately described as 7 French.
Jun 9, 2005	Z-0941-05	—	terminated	The reorder number listed on the product label is inaccurate.
Jun 9, 2005	Z-0940-05	—	terminated	The reorder number listed on the product label is inaccurate.
Apr 1, 2005	Z-0699-05	—	terminated	The expiration date listed on the product label is greater than the vendor recommended expiration date.
Apr 1, 2005	Z-0698-05	—	terminated	The expiration date listed on the product label is greater than the vendor recommended expiration date.
May 26, 2004	Z-1003-04	—	terminated	The nasal transfer tube may be missing from the package of the affected lot.
Apr 21, 2004	Z-0906-04	—	terminated	The snares inside the box labeled SASM-1 may actually be ASM-1 devices. The individual pouches may be correctly labeled ASM.
Apr 21, 2004	Z-0908-04	—	terminated	The guiding catheter provided with the SIS-10 biliary stent introduction system may be a 5 French instead of the required 6 French guiding catheter.
Jan 15, 2004	Z-0536-04	—	terminated	Product label lacks the symbols specifying the meaning of the manufacturing and expiration date.
Dec 22, 2003	Z-0347-04	—	terminated	Mislabeling; Incorrect statement, Minimum Accessory Channel Size: 3.7mm, should state, Minimum Accessory Channel Size 4.2mm
Dec 17, 2003	Z-0301-04	—	terminated	Wire-Guided Sphinterotomes may be packaged with an incorrect wire guide label.
Oct 8, 2003	Z-0048-04	—	terminated	Product may be packaged with an incorrect instructions for use (IFU) booklet.
Sep 15, 2003	Z-1292-03	—	terminated	The product was labeled 'esophageal', but contained a 'biliary' ballon
Jul 25, 2003	Z-0080-04	—	terminated	The label is missing the Rx Only symbol.
Jan 30, 2003	Z-1410-04	—	terminated	Label contains the 'Sterile EO' symbol, however the device is provided non-sterile.
Aug 28, 2002	Z-0068-04	—	terminated	The product was labeled with a 5 year expiration date instead of a 1 year expiration date.
Aug 21, 2002	Z-0089-04	—	terminated	Complaints were reported of difficulty in stent deployment.
Apr 23, 2002	Z-0079-04	—	terminated	There is a possibility that the affected devices would not capture a biopsy during a procedure.
Jan 8, 2002	Z-1180-03	—	terminated	The inner catheter of the introducer system may break after stent deployment.
Jan 8, 2002	Z-1179-03	—	terminated	The inner catheter of the introducer system may break after stent deployment.
Jan 8, 2002	Z-1181-03	—	terminated	The inner catheter of the introducer system may break after stent deployment.