Wilson-Cook Medical Instinct Plus Endoscopic Clipping Device recalled for malfunction risk
Wilson-Cook Medical is recalling Instinct Plus Endoscopic Clipping Devices (model G58010) due to increased complaints about potential device malfunction during use. The recall affects units manufactured between September 2, 2023 and April 20, 2025 and distributed worldwide. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Wilson-Cook recalls
What to do
- Stop using affected Instinct Plus clipping devices immediately if you have them in stock
- Contact Wilson-Cook Medical or your distributor for instructions on device return or replacement
- Check the UDI (01)10827002580104 and manufacturing dates on your devices to confirm if affected
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
- Sold in
- Nationwide
- Made for
- All ages
Details
- Units affected
- 713,702 units
- Illnesses reported
- None reported
- Manufactured in
- 4900 Bethania Station Rd, N/A, Winston Salem, NC, United States
- Classification
- Class II
- Recall number
- Z-1812-2026
In the FDA's words
- Description
- Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO Due to increased in complaints their is the potential for endoscopic clipping device to malfunction. 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. Affected quantity: 713,702 units
- Hazard
- Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.
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ModerateFDASep 23, 2026