CLASS II ONGOING Device recall · Reported 22 Apr 2026 · FDA Enforcement Report

Instinct Plus Endoscopic Clipping Device recalled by Wilson-Cook Medical

Wilson-Cook Medical is recalling Instinct Plus Endoscopic Clipping Device, distributed nationwide in the US. The recall was initiated on 3 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Lots manufactured between 9/2/2023-04/20/2025 ; UDI: (01)10827002580104

Quantity recalled713,702 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1812-2026
FDA event ID: 98488
Recalling firm: Wilson-Cook Medical, Winston Salem, NC
Classification: Class II
Status: Ongoing
Recall initiated: 3 Mar 2026
FDA classified: 13 Apr 2026
Reported: 22 Apr 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

3 Mar 2026	Recall initiated by company
13 Apr 2026	Classified by FDA	+41 days
22 Apr 2026	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Is Instinct Plus Endoscopic Clipping Device recalled?

Yes. Wilson-Cook Medical recalled Instinct Plus Endoscopic Clipping Device on 3 Mar 2026. The recall is Class II and its status is Ongoing. Recall number Z-1812-2026.

Why was it recalled?

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

Which lots are affected?

All Lots manufactured between 9/2/2023-04/20/2025 ; UDI: (01)10827002580104

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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