Hangzhou, N/A, China
HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. recalls
1 recall recorded since 2018, most recently on 25 April 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class III Medical devices
- Recall started
- 25 April 2025
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1976-2025
- AcoSound. Model Number: LW12-BTE-M
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.