Crimson Trace Corporation laser sights — Class II medical device recall Z-1361-2018
Terminated recall by Crimson Trace Corporation, reported 2018-05-02, distributed nationwide. A previously "in specification" Finished Product with a Model 25-0657 diode had power output higher than 5 mW.
| Recall number | Z-1361-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Crimson Trace Corporation, Wilsonville, OR, United States |
| Recall initiated | 2017-10-10 |
| Classified | 2018-04-23 |
| Reported by FDA | 2018-05-02 |
| Terminated | 2019-11-22 |
| Distributed | Nationwide (US) |
| Quantity | 184,390 |
Product
Crimson Trace Corporation laser sights. The Finished Products are laser sighting systems for firearms, used for personal defense and target acquisition.
Reason for recall
A previously "in specification" Finished Product with a Model 25-0657 diode had power output higher than 5 mW.
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-1361-2018. 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.