FDA Medical devices recall ·
Instinct Plus Endoscopic Clipping Device recall
- Recall number
- Z-1812-2026
- Date
- (initiated March 3, 2026)
- Company / brand
- Wilson-Cook Medical Inc.
4900 Bethania Station Rd, Winston Salem, NC, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 713,702 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
Why was it recalled?
Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1812-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.