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Recall Observatory FDA recall evidence

Device product

Molding Equipment. WCM series. Model WCM-330GL-i

Z-2150-2025

April 07, 2025

Class II

Product summary

Firm
Apic Yamada America
Event
Event 97241
Status
Ongoing
Classification
Class II
Quantity
6
Official record key
device-enforcement:Z-2150-2025

Official wording

Reason: 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.

Code information: None.

Distribution pattern: US

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.