FDA recall, , Moderate risk
Cook Instinct Plus Endoscopic Clipping Device
The Instinct Plus Endoscopic Clipping Device may malfunction due to increased complaints.
Summary by Recall Canary from the FDA notice
What happened
Wilson-Cook Medical Inc., of Winston Salem, North Carolina, recalled the Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO because of increased complaints indicating the potential for the endoscopic clipping device to malfunction. The company began the recall on March 3, 2026, and the FDA added it to its Enforcement Report on April 13, 2026. The device was distributed worldwide, including nationwide in the United States and in many other countries.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
- UDI-DI
- 10827002580104
- Lot code
- All Lots manufactured between 9/2/2023-04/20/2025 ; UDI: (01)10827002580104
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution including in the states of Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, GU, 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 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.
- Company
- Wilson-Cook Medical Inc.Winston Salem, North Carolina
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98488
- Recall number
- Z-1812-2026
- Quantity recalled
- 713,702 units
All recalls from Wilson-Cook Medical Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
