YAMAHA MOTOR CORPORATION: Device Recall

Recall #Z-1815-2024 · 04/17/2024

Class II: Risk

Recall Details

Recall Number
Z-1815-2024
Classification
Class II
Product Type
Device
Recalling Firm
YAMAHA MOTOR CORPORATION
Status
Ongoing
Date Initiated
04/17/2024
Location
Marietta, GA, United States
Voluntary/Mandated
FDA Mandated
Product Quantity
376

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.

Product Description

Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series. Affected models: YSM10, YSM20R(SV)-1, YSM20R(SV)-2, YSM20R-1, YSM20R-2, YSM20-1, YSM20-2, YSM20W-2, YRM20-1, YRM20-2, SIGMA-G5S2, S20, M20 ***Updated as of 6/10/2024*** Surface Mounter model S10, YC8. Component Dispenser model YSD

Distribution Pattern

US Nationwide

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.