Summary
The FDA issued a Class II for Molding Equipment. WCM series. Model WCM-330GL-i by Apic Yamada America. 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 .
Details
Source
Device Recall
External ID
Z-2150-2025
Action Date
2025-08-06
Status
Ongoing
Category
device
Product Description
Molding Equipment. WCM series. Model WCM-330GL-i
Lot/Code Info: None.
Quantity Affected: 6
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.
Distribution
US
Type: FDA Mandated
Recall Initiated: 2025-04-07
Company
Chandler, AZ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 157 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Apic Yamada America) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Apic Yamada America have FDA actions?
This is the only FDA action we have on record for Apic Yamada America in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2150-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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