11-VI Incorporated Laser diode component Non-certified laser diode… — Class II medical device recall Z-1614-2018
Terminated recall by Ii - Vi Incorporated, reported 2018-06-13, distributed in OR. Affected diodes incorporated in the laser sights emitted greater than the 5 mW limit.
| Recall number | Z-1614-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Ii - Vi Incorporated, Saxonburg, PA, United States |
| Recall initiated | 2017-12-13 |
| Classified | 2018-06-02 |
| Reported by FDA | 2018-06-13 |
| Terminated | 2020-04-22 |
| Distributed | OR |
| Quantity | 323,972 |
| Model numbers | 25-0655, 25-0657 |
Product
11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms
Reason for recall
Affected diodes incorporated in the laser sights emitted greater than the 5 mW limit.
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-1614-2018. 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.