FDA DevicesClass II
Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
Published: April 22, 2026Recall ID: Z-1812-2026Category: devicesCountry: US
Reason for Recall / Hazard
Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.
Product Description & Identification
Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
Affected Products
Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
Additional Source Details
| Field | Value |
|---|---|
| City | Winston Salem |
| State | NC |
| Event id | 98488 |
| Address 1 | 4900 Bethania Station Rd |
| Address 2 | N/A |
| Code info | All Lots manufactured between 9/2/2023-04/20/2025 ; UDI: (01)10827002580104 |
| Postal code | 27105-1203 |
| Report date | 20260422 |
| Product type | Devices |
| Product quantity | 713,702 units |
| Reason for recall | Due to increased in complaints their is the potential for endoscopic clipping device to malfunction. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260303 |
| Initial firm notification | Letter |
| Center classification date | 20260413 |
Overview
- Recalling FirmWilson-Cook Medical Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - 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.