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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 and EverPatch+ Recalled for Risk of Early Exposure

Agency Publication Date: October 3, 2025
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Summary

CorNeat Vision, Ltd. is recalling approximately 810 units of its EverPatch and EverPatch+ permanent surgical matrices. This recall includes 630 units of the EverPatch and 180 units of the EverPatch+ model. The recall was initiated after complaints indicated that the surgical wound (conjunctival dehiscence) could open prematurely, leading to early exposure of the surgical patch before it has fully integrated into the patient's tissue. Healthcare providers should stop using these specific products and contact the manufacturer or their distributor for instructions.

Risk

If the surgical wound opens too early, the implanted patch can become exposed to the environment. This may compromise the surgical outcome and could potentially require additional medical procedures to correct the issue.

What You Should Do

  1. This recall affects CorNeat EverPatch (REF 1036295, UDI G16010362950) and EverPatch+ (REF 1044002, UDI G16010440020) surgical matrices.
  2. Identify the affected products by checking the label for REF numbers 1036295 or 1044002 and UDI codes G16010362950 or G16010440020.
  3. Stop using the recalled surgical matrices immediately.
  4. Contact CorNeat Vision, Ltd. or your distributor to arrange for the return, replacement, or correction of any unused inventory.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding medical device recalls.

Your Remedy Options

📋Other Action
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 (5.0 mm x 6.5 mm x 100 micrometers)
Model / REF:
1036295
Lot Numbers:
All Lots
UDI:
G16010362950

Quantity: 630 units

Product: EverPatch+ Permanent Scleral Reinforcement Matrix (1 x 5.0mm x 8.5 mm Shield / 1 x 5.0mm x 6.5 mm Rectangle)
Variants: STERILE VH2O2
Model / REF:
1044002
Lot Numbers:
All Lots
UDI:
G16010440020

Quantity: 180 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97463
Status: Active
Manufacturer: CORNEAT VISION, LTD.
Sold By: Medical distributors; Direct to hospitals
Manufactured In: Israel
Units Affected: 2 products (630 units; 180 units)
Distributed To: Arizona, California, Colorado, Connecticut, District of Columbia, 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

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 · 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.