The Recall Desk
HighFDA (Devices)·Z-1815-2024·Announced 2024-05-29

Yamaha Surface Mounter Equipment Recalled for Missing Laser Safety Certification Labels

Yamaha is recalling certain surface mounter equipment models because they lack required certification labels for laser safety compliance under FDA regulations.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Missing required certification labels on laser products represents a risk-of-harm situation where operators lack required safety information. Laser products can cause serious injury, and the absence of compliance certification creates an uncorrected safety risk.

Plain-English summary

Yamaha Motor Corporation is recalling certain surface mounter equipment models due to non-compliance with 21 C.F.R. § 1010.2. The affected units do not bear the required certification label for laser safety.

The recall affects multiple Yamaha surface mounter models including the YR, YS, i-Pulse, and Sigma series equipment. Approximately 376 units were distributed nationwide in the United States.

Owners of affected equipment should contact Yamaha Motor Corporation for remediation regarding certification labeling compliance.

The recalled product

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 Mounte
Manufacturer
YAMAHA MOTOR CORPORATION
Category
Other — Industrial Manufacturing Equipment
Hazard
  • laser-safety
  • missing-certification-label

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

  • 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

Distribution

Distributed nationwide across the United States.