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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/Implants & Prosthetics

CorNeat EverPatch Recalled for Labeling Correction on Wound Dehiscence

Agency Publication Date: September 5, 2025
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Summary

CorNeat Vision is recalling the CorNeat EverPatch, a permanent tissue-integrating surgical matrix used in medical procedures. This recall is a labeling correction intended to provide surgeons with better information on how to prevent and manage wound dehiscence, which is when a surgical incision reopens. The company initiated the recall after receiving complaints regarding the device's performance related to this issue.

Risk

Incomplete labeling regarding the management of surgical wound reopening could lead to improper patient care or surgical complications. While complaints have been received, specific injury counts were not provided by the manufacturer.

What You Should Do

  1. This recall affects the CorNeat EverPatch (REF 1036295), which is a sterile, permanent tissue-integrating surgical matrix measuring 5.0 mm x 6.5 mm x 100 um.
  2. Identify affected units by checking the device packaging for UDI-DI G16010362950 and catalog reference number (REF) 1036295.
  3. Stop using the recalled device. Contact CorNeat Vision, Ltd. or your authorized medical distributor to arrange for a labeling correction, replacement, or return of the product.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action

Labeling Correction

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: CorNeat EverPatch Permanent Tissue-Integrating Surgical Matrix
Variants: 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
Model / REF:
1036295
UDI:
G16010362950

Recall #: Z-2537-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97281
Status: Active
Manufacturer: CORNEAT VISION, LTD.
Sold By: Authorized medical distributors
Manufactured In: Israel
Distributed To: Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, Puerto Rico

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.