FDA Device recall Z-0039-2026
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m
- FDA Device
- Class II
- ongoing
- Published 2025-10-15
On 2025-10-15 the FDA classified a Class II recall of CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m by Corneat Vision, citing reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0039-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-18 |
| Published | 2025-10-15 |
| 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 605 mm x 100 ¿m
Reason
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Identifiers
| code_info | All Lots/ UDI: 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-0039-2026%22
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