HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.: Device Recall
Recall #Z-1976-2025 · 04/25/2025
Class III: Low Risk
Recall Details
- Recall Number
- Z-1976-2025
- Classification
- Class III
- Product Type
- Device
- Recalling Firm
- HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.
- Status
- Ongoing
- Date Initiated
- 04/25/2025
- Location
- Hangzhou, N/A, China
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 120 units
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.
Product Description
AcoSound. Model Number: LW12-BTE-M
Distribution Pattern
US Nationwide distribution in the state of New York.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.