Optical Inspection System — Class II medical device recall Z-1816-2024
Ongoing recall by YAMAHA MOTOR CORPORATION, reported 2024-05-29, distributed nationwide. Non-medical laser products which were determined to not be in compliance with 21 C.F.R. ¿ 1010.2 in that they
| Recall number | Z-1816-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | YAMAHA MOTOR CORPORATION, Marietta, GA, United States |
| Recall initiated | 2024-04-17 |
| Classified | 2024-05-20 |
| Reported by FDA | 2024-05-29 |
| Distributed | Nationwide (US) |
| Quantity | 67 |
| Reason classes | labeling |
Product
Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2), YRi-V
Reason for recall
Non-medical laser products which were determined to not be in compliance with 21 C.F.R. ¿ 1010.2 in that they currently do not bear the required certification label.
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-1816-2024. 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.