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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Instinct Plus Endoscopic Clipping Device Recalled for Potential Malfunction

Agency Publication Date: April 13, 2026
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Summary

Wilson-Cook Medical Inc. is recalling approximately 713,702 units of the Instinct Plus Endoscopic Clipping Device due to an increase in reports that the device may malfunction during use. This voluntary recall was initiated following complaints regarding the potential for device failure, which could impact surgical procedures. The affected medical devices were manufactured between September 2023 and April 2025 and distributed worldwide to hospitals and surgical centers. You should stop using the recalled device and contact the manufacturer or your distributor to arrange for its return or replacement.

Risk

The clipping device may fail to function as intended during endoscopic procedures, which could lead to surgical delays, ineffective treatment, or internal injury. While there have been reports of malfunctions, no specific injury count was provided in the notification.

What You Should Do

  1. Identify if you have the Instinct Plus Endoscopic Clipping Device by checking the product label for Reference Number (REF) G58010 and the UDI code (01)10827002580104.
  2. Check the manufacturing date to see if your unit was produced between September 2, 2023, and April 20, 2025.
  3. Stop using the recalled device immediately to prevent potential malfunctions during clinical procedures.
  4. Contact Wilson-Cook Medical Inc. or your local distributor to arrange for the return, replacement, or correction of the affected units.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Instinct Plus Endoscopic Clipping Device
Variants: Sterile EO
Model / REF:
G58010
UDI:
(01)10827002580104
Date Ranges: Manufactured between 9/2/2023-04/20/2025

Rx Only; All lots manufactured within the specified date range are affected.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98488
Status: Active
Manufacturer: Wilson-Cook Medical Inc.
Sold By: Medical distributors; Hospitals; Surgical centers
Manufactured In: United States
Units Affected: 713,702
Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.