Class II — OCULOGICA
| Recalling firm | Oculogica Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A review of the user manual revealed that two precaution statements were missing. |
| Product | EyeBOX Model OCL 02 |
| Quantity | 3 |
| Distribution | The products were distributed to the following US states: MD and NY |
| Initiated | 2019-04-16 |
| Classified | 2019-08-27 |
| Terminated | 2020-04-10 |
| Recall number | Z-2398-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — OCULOGICA (Z-2398-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82922/
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