Z-1815-2024Class II

Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series. Affected...

Name: Z-1815-2024 Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series. Affected...
Creator: Yamaha Motor Corporation
Published: 2024-04-17
License: https://open.fda.gov/license/

Yamaha Motor Co Ltd / initiated 2024-04-17 / Open, Classified / root cause: labeling and UDI

FDA source

YAMAHA MOTOR CORPORATION began a recall of 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... on 2024-04-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1815-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-17
Posted: 2024-05-20
Recalling firm: Yamaha Motor Co Ltd
Product: 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
Product code: RGA Product Incorporating Certified Class 1 Data Utility/Peripheral Laser Product
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.
Root cause tag: labeling and UDI
FDA root cause: Radiation Control for Health and Safety Act
Action: Yamaha Motor Robotics has recently discovered that certain products may be out of compliance with FDA electronic product regulations in that they did not bear a required label at the time they were shipped. Our records indicate that you have received one or more of the products affected by this problem. In this packet, we are providing you with the missing labels and instructions on their placement to correct this matter. These actions are being taken at no expense to you. Corrective Action Instructions: 1. Please locate the certification labels provided in this packet. (If you need more, please contact the Corrective Action Plan Coordinator at [email protected] or (770) 420-5825 and we will send you more at no expense to you). 2. Following the label placement instructions for your product found below, affix the label in the indicated position. 3. Download the revised user manuals from the "YAMAHA Surface Mounter Support & Service" website (https://www.yamaha-smtservice.net/en/).
Quantity in commerce: 376
Distribution: US Nationwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1815-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1815-2024	Class II	Ongoing	FDA Mandated	2024-05-29	2024-05-20
Z-1816-2024	Class II	Ongoing	FDA Mandated	2024-05-29	2024-05-20

Product code RGA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)