FDAFDA · Food and drugs·Recall number Z-1815-2024
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
Published May 29, 2024 · Recall initiated: April 17, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
FDA Mandated · Letter
Recall details
- Manufacturer
- YAMAHA MOTOR CORPORATION
- Distributor
- US Nationwide
- Lot
- YR series Model YRM20-1, YRM20-2 YS series Model YC8, YSM10 YSM20-1, YSM20-2, YSM20W-2 YSM20R-1, YSM20R-2, YSM20R(SV)-1, YSM20R(SV)-2 i-PULSE series Model S10, S20, M20 Sigma series Model SIGMA-G5S2
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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