Data Foundry

Medical device recalls 2025

Molding Equipment — Class II medical device recall Z-2150-2025

Ongoing recall by Apic Yamada America, reported 2025-08-06. Apic Yamada has recently discovered that certain products may be out of compliance with FDA electronic product

Recall numberZ-2150-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedFDA mandated
Recalling firmApic Yamada America, Chandler, AZ, United States
Recall initiated2025-04-07
Classified2025-07-31
Reported by FDA2025-08-06
Quantity6
Reason classeslabeling
Model numbersWCM-330GL-I

Product

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

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2150-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.