CORNEAT VISION, LTD.: Medical Device Recall in 2025 - (Recall #: Z-2537-2025)

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 6.5 mm x 100 um, SterileEO, RX only

Product Classification:

Class II

Date Initiated: October 16, 2024

Date Posted: September 17, 2025

Recall Number: Z-2537-2025

Event ID: 97281

Reason for Recall:

Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.

Status: Ongoing

Product Quantity: N/A

Code Information:

UDI-DI: G16010362950

Distribution Pattern:

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico and the countries of Argentina, Israel, Hong Kong.

Voluntary or Mandated:

Voluntary: Firm initiated