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.

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: [email protected]. 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.