CORNEAT VISION, LTD.: Medical Device Recall in 2025 - (Recall #: Z-0039-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 18, 2025

Date Posted: October 15, 2025

Recall Number: Z-0039-2026

Event ID: 97463

Reason for Recall:

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

Status: Ongoing

Product Quantity: 630 units

Code Information:

All Lots/ UDI: G16010362950

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated