FDA Medical devices recall ·
Molding Equipment recall
- Recall number
- Z-2150-2025
- Date
- (initiated April 7, 2025)
- Company / brand
- Apic Yamada America
104 S 54th St, Chandler, AZ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 6
- Initiated by
- FDA Mandated
Read the official FDA notice ↗
Product
Molding Equipment. WCM series. Model WCM-330GL-i
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
None.
Distribution
US
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2150-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.