MX-10 surveillance laser system Product Usage: The expected usage of… — Class II medical device recall Z-2316-2018
Terminated recall by Wescam Inc, reported 2018-07-25, distributed nationwide. Product has a nominal ocular hazard distance (NOHD) that is longer than specified and persons could be exposed
| Recall number | Z-2316-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Wescam Inc, Burlington, Ontario, Canada |
| Recall initiated | 2018-05-08 |
| Classified | 2018-07-15 |
| Reported by FDA | 2018-07-25 |
| Terminated | 2021-08-24 |
| Distributed | Nationwide (US) |
| Quantity | 29 |
| Model numbers | 44620-203, 44620-211, 44620-213, 44620-215, 44620-221, 44620-263, 44620-277, 45840-13, 45840-20, 45840-23, 4620-258 |
Product
MX-10 surveillance laser system Product Usage: The expected usage of the product is to facilitate observation and surveillance missions from safe standoff ranges.
Reason for recall
Product has a nominal ocular hazard distance (NOHD) that is longer than specified and persons could be exposed to light in excess of the exposure 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-2316-2018. 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.