Recall Z-1812-2026 ยท PKL Hemostatic Metal Clip For The Gi Tract
Wilson-Cook Medical Inc.
Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
| Date | Apr 13, 2026 (initiated Mar 3, 2026) |
| Status | Open, Classified |
| Reason | Due to increased in complaints their is the potential for endoscopic clipping device to malfunction. |
| Root cause | Process control |
| Action | On March 2, 2026, Cook Medical, issued a "Urgent: Medical Device Recall" Notification to affected consignees via: Fed Ex. Cook Medical asked consignees to take the following actions: 1. Examine inventory immediately to determine if you have affected devices. Immediately cease use of the affected devices and quarantine all affected devices. 2. Return the affected devices to Cook Medical. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. 4. This notice must be shared with appropriate personnel, including down to the user level, within y |
| Quantity | 713,702 units |
| 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, AUS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212323 | Instinct Plus Endoscopic Clipping Device Wilson-Cook Medical, Inc., Aug 25, 2021 |