Apic Yamada America recalls 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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Molding Equipment. WCM series. Model WCM-330GL-i
Lot / code information
None.
What the firm is doing
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.
DistributionShow detailsHide
US
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2150-2025
- FDA device classification · RHKOfficial FDA classification for this device type
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Apic Yamada AmericaSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
More Class II recalls
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) BASIC PACK
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Eye Tray
- Nonconforming Material/Component
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Orthopedic Tray
- Nonconforming Material/Component
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Neurological Tray
- Nonconforming Material/Component
