Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO

FDA device recall Z-1812-2026 · posted 2026-04-13 · Open, Classified

Recall details

Recalling firm

Wilson-Cook Medical Inc.

Reason for recall

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

Action taken

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 your organization or with any organization where the potentially affected devices have been transferred. 5. Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: CustomerRelationsNA@CookMedical.com. 6. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA: http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm. Call the FDA at 800.FDA.1088.

Root cause

Process control

Status

Open, Classified

Product code

PKL

Quantity affected

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

Date initiated

2026-03-03

Date posted

2026-04-13

Location

Winston Salem, NC

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