WCM Series Molding Equipment (Apic Yamada) – FDA Compliance Issue (2025)
Some molding equipment may lack a required FDA label.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Molding Equipment. WCM series. Model WCM-330GL-i
Brand
Apic Yamada America
Lot Codes / Batch Numbers
None.
Products Sold
None.
Apic Yamada America is recalling Molding Equipment. WCM series. Model WCM-330GL-i due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Apic Yamada Corporation (AYC) sends notification letters to customers and provides the following information including affected product description, details on the issue and Corrective Action Instructions To complete the remediation of affected products, the our FSE will follow these steps: 1. Please locate the certification labels provided in this packet. 2. Following the label placement instructions for your product found below, affix the label in the indicated position.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026