CORNEAT VISION, LTD.: Device Recall

Recall #Z-2537-2025 · 10/16/2024

Class II: Risk

Recall Details

Recall Number: Z-2537-2025
Classification: Class II
Product Type: Device
Recalling Firm: CORNEAT VISION, LTD.
Status: Ongoing
Date Initiated: 10/16/2024
Location: Ra'Anana, N/A, Israel
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: N/A

Reason for Recall

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

Product Description

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

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.

Other Recalls by CORNEAT VISION, LTD.

Class II: Risk 08/18/2025

Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Class II: Risk 08/18/2025

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

View all recalls by CORNEAT VISION, LTD. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.