BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-1812-2026 · Reported April 22, 2026

    Enforcement

    Recall Number
    Z-1812-2026
    Event ID
    98488
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Wilson-Cook Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 22, 2026
    Initiation Date
    March 3, 2026
    Classification Date
    April 13, 2026
    Address
    4900 Bethania Station Rd, N/A, Winston Salem, NC, 27105-1203, United States

    Description

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

    Reason

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

    Code Info

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

    Distribution

    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.

    Quantity

    713,702 units