Data Foundry

Medical device recalls 2025

EverPatch+ — Class II medical device recall Z-0040-2026

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 numberZ-0040-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmCORNEAT VISION, LTD., Ra'Anana, Israel
Recall initiated2025-08-18
Classified2025-10-03
Reported by FDA2025-10-15
DistributedNationwide (US)
Countries outside the USAR, HK, IL, JP
Quantity180 units
Model numbers1044002

Product

EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH202

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-0040-2026. 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.