Molding Equipment Missing Required FDA Electronic Product Regulatory Label
Apic Yamada America is recalling 6 units of WCM-330GL-i molding equipment that lacks required FDA electronic product labeling. The affected units do not bear labels required for compliance with FDA regulations.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II FDA device recall for a labeling compliance issue with no reported illnesses, injuries, or deaths. The hazard is a documentation deficiency rather than a reported safety incident, consistent with Moderate severity criteria.
Plain-English summary
Apic Yamada America is recalling 6 units of its WCM series Model WCM-330GL-i molding equipment distributed in the United States. The equipment does not bear labeling required by FDA electronic product regulations.
The recalled equipment is non-compliant because it lacks the required FDA regulatory labels. These labels are mandated by federal electronic product regulations for electronic equipment.
If you possess this equipment, contact Apic Yamada America for instructions on remediation or replacement. For additional information, refer to FDA recall number Z-2150-2025.
The recalled product
- Product
- Molding Equipment. WCM series. Model WCM-330GL-i
- Manufacturer
- Apic Yamada America
- Hazard
- mis-labeling
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 (1)
- None.
Distribution
Distribution scope not specified by the agency.
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