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FDA-Device2026-04-22Class IIPROCESSING DEFECT

Wilson-Cook Medical Instinct Plus Endoscopic Clipping Device recalled for malfunction risk

Wilson-Cook
OTHERNationwide distribution

Stop using Wilson-Cook Instinct Plus clipping devices

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.

  • 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
Hazard

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

Sold states
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 count
713,702 units
Manufactured in
4900 Bethania Station Rd, N/A, Winston Salem, NC, United States
Products
Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1812-2026

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