Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
Summary
The FDA issued a Class II for Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO by Wilson-Cook Medical Inc.. Reason: Due to increased in complaints their is the potential for endoscopic clipping device to malfunction..
Details
Source
Device Recall
External ID
Z-1812-2026
Action Date
2026-04-22
Status
Ongoing
Category
device
Product Description
Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
Lot/Code Info: All Lots manufactured between 9/2/2023-04/20/2025 ; UDI: (01)10827002580104
Quantity Affected: 713,702 units
Reason for Recall
Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-03
Company
Winston Salem, NC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 143 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Wilson-Cook Medical Inc. has 19 FDA actions in our database, including 16 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Wilson-Cook Medical Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Wilson-Cook Medical Inc. have FDA actions?
Wilson-Cook Medical Inc. has 19 FDA actions in our database, including 16 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1812-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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