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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- YAMAHA MOTOR CORPORATION
- Category
- Other — Industrial Manufacturing Equipment
- Affected units
- 376
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.
Part of a larger recall action
This product is one of 2 recalled by YAMAHA MOTOR CORPORATION under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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