FDAClass IIOctober 15, 2025

CorNeat EverPatch recall

CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m

Why was CorNeat EverPatch recalled?

Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All Lots/ UDI: G16010362950

Product
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m
Recalling firm
CORNEAT VISION, LTD.
Quantity
630 units
Distribution
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI and the countries of Japan, Israel, Argentina, Hong Kong.
Recall date
October 15, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls