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Wilson-Cook Medical Inc.: Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO

Medical DevicesSource: FDA (device) · Date: 2026-04-22

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Wilson-Cook Medical Inc.
Product
Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
Reason / hazard
Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Argentina, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, Brunei, Darussalam, Brazil, Canada, CANARY ISLANDS, Chile, China, Colombia, Costa Rica, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, Egypt, FINLAND, FRANCE, GERMANY, GREECE, Guatemala, Hong Kong, HUNGARY, Indonesia, India, IRELAND, ISRAEL, ITALIA, KUWAIT, LEBANON, LUXEMBOURG, MALTA, MAYOTTE, Mexico, Macao, MOROCCO, Malaysia, NEDERLAND, NORWAY, New Zealand, OMAN, PAKISTAN, Peru, POLAND, PORTUGAL, QATAR, REUNION, ROMANIA, SAUDI ARABIA, SLOVENIA, El Salvador, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, Thailand, TURKEY, Taiwan, United Arab Emirates, United Kingdom.
Recall initiated
2026-03-03
Code info
All Lots manufactured between 9/2/2023-04/20/2025 ; UDI: (01)10827002580104
Product quantity
713,702 units
Voluntary mandated
Voluntary: Firm initiated
City
Winston Salem
State
NC
Country
United States
Event id
98488
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