AcoSound. Model Number: LW12-BTE-M
Recall
- Recall Number
- Z-1976-2025
- Event Number
- 96904
- Firm
- HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. No.2 Building Room 401 No.
- FEI Number
- 3011350813
- Product Code
- QUG
- Status
- Open, Classified
- Root Cause
- Labeling design
- Initiated
- April 25, 2025
- Posted
- June 13, 2025
- Address
- 1390 Cangxing Street, Yuhang Hangzhou, China
Description
AcoSound. Model Number: LW12-BTE-M
Three issues 1. Label error: The manufacturer information in the labeling is not correct, the manufacturer's name is mislabeled as "Developed by AcoSound," Correct should be "Manufactured by Hangzhou AcoSound." And the labeling has no statement of the place of business for the manufacturer. 2. Customer information: The customer "Blaid" information is not correctly marked; Blaid is not the manufacturer. 3. UDI Information: The UDI information is incomplete and without DI information and correct Pl information, not complied with UDI label requirements.
The firm notified its single consignee/importer on about 04/25/2025 via email. The notification instructed the importer to examine inventory and arrange for replacement labels. The importer notified their consignees from 05/01-20/2025 of the recall via email or telephone. They instructed their customers that that the product label needs to be updated and provided the arrangement for replacing the label.
US Nationwide distribution in the state of New York.
120 units