FDA Device recall Z-2537-2025
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
- FDA Device
- Class II
- ongoing
- Published 2025-09-17
On 2025-09-17 the FDA classified a Class II recall of CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only by Corneat Vision, citing retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2537-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-16 |
| Published | 2025-09-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Corneat Vision |
| Distribution | US |
Product
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
Reason
Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
Identifiers
| code_info | UDI-DI: G16010362950 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2537-2025%22
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