FDA Recall
Open, Classified
Molding Equipment. WCM series. Model WCM-330GL-i
Recall: Z-2150-2025
·
Initiated April 7, 2025
Recall
- Recall Number
- Z-2150-2025
- Event Number
- 97241
- Firm
- Apic Yamada America
- FEI Number
- 3005760957
- Product Code
- RHK
- Status
- Open, Classified
- Root Cause
- Radiation Control for Health and Safety Act
- Initiated
- April 7, 2025
- Posted
- July 31, 2025
- Address
- 104 S 54th St, Chandler, AZ, 85226
Description
Molding Equipment. WCM series. Model WCM-330GL-i
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.
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.
Distribution
US
Quantity
6