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Recall Observatory FDA recall evidence

Device product

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

Z-1812-2026

March 03, 2026

Class II

Product summary

Firm
Wilson-Cook Medical Inc.
Event
Event 98488
Status
Ongoing
Classification
Class II
Quantity
713,702 units
Official record key
device-enforcement:Z-1812-2026

Official wording

Reason: Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.

Code information: All Lots manufactured between 9/2/2023-04/20/2025 ; UDI: (01)10827002580104

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.