EyeBOX Model OCL 02 — Class II medical device recall Z-2398-2019
Terminated recall by OCULOGICA, reported 2019-09-04, distributed in MD, NY. A review of the user manual revealed that two precaution statements were missing.
| Recall number | Z-2398-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OCULOGICA, New York, NY, United States |
| Recall initiated | 2019-04-16 |
| Classified | 2019-08-27 |
| Reported by FDA | 2019-09-04 |
| Terminated | 2020-04-10 |
| Distributed | MD, NY |
| Quantity | 3 |
| Serial numbers | TT003, TT004, TT005 |
Product
EyeBOX Model OCL 02
Reason for recall
A review of the user manual revealed that two precaution statements were missing.
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-2398-2019. 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.