Z-1812-2026Class II

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

Name: Z-1812-2026 Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
Creator: Wilson-Cook Medical Inc.
Published: 2026-03-03
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2026-03-03 / Open, Classified / root cause: manufacturing process

FDA source

Wilson-Cook Medical Inc. began a recall of Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO on 2026-03-03. FDA classified it as Class II and gives the reason as "Due to increased in complaints their is the potential for endoscopic clipping device to malfunction". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1812-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-03
Posted: 2026-04-13
Recalling firm: Wilson-Cook Medical Inc.
Product: Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
Product code: PKL Hemostatic Metal Clip For The Gi Tract
Reason for recall: Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.
Root cause tag: manufacturing process
FDA 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 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.
Quantity in commerce: 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, 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.
Product codes and lots: All Lots manufactured between 9/2/2023-04/20/2025 ; UDI: (01)10827002580104

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1812-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1812-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-22	2026-04-13

Product code PKL

K212323Class IIInstinct Plus Endoscopic Clipping DeviceWilson-Cook Medical, Inc. / cleared 2021-08-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)