Class 2 Device Recall Model WCM330GLi

• Date Initiated by Firm: April 07, 2025
• Date Posted: July 31, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2150-2025
• Recall Event ID: 97241
• Product Classification: Laser marker or engraver, industrial or commercial - Product Code RHK
• Product: Molding Equipment. WCM series. Model WCM-330GL-i
• Code Information: None.
• FEI Number: 3005760957
• Recalling Firm/ Manufacturer: Apic Yamada America; 104 S 54th St; Chandler AZ 85226
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Radiation Control for Health and Safety Act
• Action: 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.
• Quantity in Commerce: 6
• Distribution: US
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.