FDA Medical Device Recalls (openFDA)
Apic Yamada America: Molding Equipment. WCM series. Model WCM-330GL-i
- Recall number
- Z-2150-2025
- Recalling firm
- Apic Yamada America
- Product
- Molding Equipment. WCM series. Model WCM-330GL-i
- Status
- Open, Classified
- Initiated
- 2025-04-07
- Posted
- 2025-07-31
- Terminated
- not on file
- 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.
- Root 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
- 6
- Distribution
- US
- Lot, serial or model codes
- None.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RHK
- Firm FEI
- 3005760957
- Firm city
- Chandler
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28