Apic Yamada molding equipment shipped without a required regulatory label
Apic Yamada WCM series molding equipment, model WCM-330GL-i, is being recalled because certain products may be out of compliance with FDA electronic product regulations for not bearing a required label. 6 units affected.
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 2/5 (Moderate).
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: FDA Class II recall for a missing required label under the electronic product regulations, which is a documentation issue with no defect stated.
Plain-English summary
Molding Equipment, WCM series, model WCM-330GL-i, from Apic Yamada, is being recalled. The action covers 6 units.
The stated reason is that Apic Yamada 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. The FDA classified the action as Class II. The source does not describe a device defect or resulting hazard.
Distribution was in the United States.
Operators should identify affected machines by model and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Molding Equipment. WCM series. Model WCM-330GL-i
- Manufacturer
- Apic Yamada America
- Category
- Other — Industrial molding equipment
- Affected units
- 6
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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