Z-1132-2019Class II

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

Name: Z-1132-2019 Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy
Creator: Wilson-Cook Medical Inc.
Published: 2019-01-04
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2019-01-04 / Terminated / root cause: manufacturing process

FDA source

Wilson-Cook Medical Inc. began a recall of Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy on 2019-01-04. FDA classified it as Class II and gives the reason as "Complaints of the snare loop not completely retracting and/or misshaping of the snare loop". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1132-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-04
Posted: 2019-04-12
Terminated: 2020-07-21
Recalling firm: Wilson-Cook Medical Inc.
Product: Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.
Product code: KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Reason for recall: Complaints of the snare loop not completely retracting and/or misshaping of the snare loop.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Cook Medical, sent an"URGENT: MEDICAL DEVICE RECALL" letter to its customers. The letter described the product, problem and actions to be taken. The customer were instructed to do the following: 1. Review the labels of impacted product shipped to your account and quarantine any affected product that remains unused. If you are a distributor and the products have been distributed, contact your customer(s) and direct them to quarantine any affected product. 2. Immediately collect and return all unused affected products at one time to Cook Medical as soon as possible. Affected product should be returned to: Cook Medical Attn: Return Goods Department 053-R 400 Daniels Way Bloomington, IN 47404 3. Complete the attached Recall Return Response form and send to Cook Medical. This form may be sent via fax using the fax number: 812-339-7316 or scanned and emailed to [email protected]. Account credit will be issued to your facility upon receipt of this form with the completed information. Should you have any questions, please contact the Customer Relations Department at Cook Medical for more information. Please use [email protected], or call us toll free 1-800-457-4500, press 4, then enter extension 15-2146. Monday through Friday, 8:00AM to 4:30PM, Eastern Time.
Quantity in commerce: 34,456 units
Distribution: Worldwide Distribution: US (nationwide) in the states of: AL, AR, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY; and countries of: ARGENTINA, BRAZIL, CANADA, MEXICO, NETHERLANDS ANTILLES, AUSTRIA, BELARUS, BELGIUM, FINLAND, FRANCE, GERMANY, ITALY, NETHERLANDS, POLAND, PORTUGAL, RUSSIAN FEDERATION, SLOVAKIA, SLOVENIA, SPAIN, SWEDEN, SWITZERLAND, UNITED ARAB EMIRATES, UNITED KINGDOM, AUSTRALIA, CHINA, INDIA, NEW ZEALAND, TAIWAN, REPUBLIC OF CHINA and THAILAND.
Product codes and lots: ASDB-15-015- S with Lot #'s W4010785, W4010787, W4010788, W4010789, W4010791, W4010792, W4010793, W4010794, W4010795, W4010796, W4010797, W4010799, W4010801, W4010802, W4010803, W4010804, W4010805, W4010806, W4012291, W4012292, W4012294, W4012295, W4012296, W4012300, W4013231, W4015568, W4015569, W4015570, W4015571, W4015572, W4015574, W4015575, W4015576, W4015577, W4015578, W4018215, W4018216, W4018217, W4018219, W4018220, W4018221, W4018222, W4018223, W4019733, W4019734, W4019735, W4019736, W4019738, W4019739, W4019742, W4019743, W4019744, W4020127, W4020128, W4020129, W4020130, W4020131, W4020132, W4020133, W4020134, W4021578, W4021579, W4021580, W4021581, W4021582, W4021583, W4021584, W4021585, W4021586, W4021587, W4021588, W4021589, W4021591, W4021598, W4023828, W4023835, W4023836, W4023837, W4023838, W4023839, W4023840, W4023841, W4023843, W4023844, W4023845, W4024369, W4024370, W4024371, W4024372, W4024373, W4024374, W4025299, W4025300, W4025301, 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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1132-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1132-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-12

Product code KNS

K851958Class IIRotatable Polypectomy Snare Pos-1Wilson-Cook Medical, Inc. / cleared 1985-07-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)