AcoSound. Model Number: LW12-BTE-M
This recall is currently active, issued June 13, 2025. It was issued by Hangzhou Acosound Technology Co., Ltd. No.2 Building Room 401 No..
- Recall Initiated
- April 25, 2025
- Posted
- June 13, 2025
- Recall Number
- Z-1976-2025
- Quantity
- 120 units
- Firm Location
- Yuhang Hangzhou, China
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Nationwide distribution in the state of New York.
Lot / Code Info
UDI: 06973375880000. Lot Number: Lot 001-120. Serial Numbers: SN110C30C580010802 to SN110C30C581200802
Root Cause
Labeling design
Action Taken
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.