Z-2150-2025Class II

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

Name: Z-2150-2025 Molding Equipment. WCM series. Model WCM-330GL-i
Creator: Apic Yamada America
Published: 2025-04-07
License: https://open.fda.gov/license/

Apic Yamada America / initiated 2025-04-07 / Open, Classified / root cause: labeling and UDI

FDA source

Apic Yamada America began a recall of Molding Equipment. WCM series. Model WCM-330GL-i on 2025-04-07. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2150-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-07
Posted: 2025-07-31
Recalling firm: Apic Yamada America
Product: Molding Equipment. WCM series. Model WCM-330GL-i
Product code: RHK Laser Marker Or Engraver, Industrial Or Commercial
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 6
Distribution: US
Product codes and lots: None.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2150-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2150-2025	Class II	Ongoing	FDA Mandated	2025-08-06	2025-07-31

Product code RHK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)