Home / Recalls / CORNEAT VISION, LTD. / Z-2537-2025

Z-2537-2025 Class II Ongoing

Recalled by CORNEAT VISION, LTD. — Ra'Anana, N/A

Recall Details

Product Type: Devices
Report Date: September 17, 2025
Initiation Date: October 16, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: N/A

Product Description

CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only

Reason for Recall

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

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.

Code Information

UDI-DI: G16010362950