CorNeat EverPatch — Class II medical device recall Z-0039-2026
Ongoing recall by CORNEAT VISION, LTD., reported 2025-10-15, distributed nationwide. Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the sur
| Recall number | Z-0039-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CORNEAT VISION, LTD., Ra'Anana, Israel |
| Recall initiated | 2025-08-18 |
| Classified | 2025-10-03 |
| Reported by FDA | 2025-10-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, HK, IL, JP |
| Quantity | 630 units |
| Model numbers | 1036295 |
Product
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m
Reason for recall
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0039-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.