BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1812-2026 · Initiated March 3, 2026

    Recall

    Recall Number
    Z-1812-2026
    Event Number
    98488
    Firm
    Wilson-Cook Medical Inc.
    FEI Number
    1037905
    Product Code
    PKL
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    March 3, 2026
    Posted
    April 13, 2026
    Address
    4900 Bethania Station Rd, Winston Salem, NC, 27105-1203

    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.

    Action

    On March 2, 2026, Cook Medical, issued a "Urgent: Medical Device Recall" Notification to affected consignees via: Fed Ex. Cook Medical asked consignees to take the following actions: 1. Examine inventory immediately to determine if you have affected devices. Immediately cease use of the affected devices and quarantine all affected devices. 2. Return the affected devices to Cook Medical. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred. 5. Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: [email protected]. 6. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA: http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm. Call the FDA at 800.FDA.1088.

    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