Class III — HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.
| Recalling firm | Hangzhou Acosound Technology Co., Ltd. |
|---|---|
| Registered facility | HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. (the firm's only registered facility) |
| Classification | Class III |
| Status | Ongoing |
| 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. |
| Product | AcoSound. Model Number: LW12-BTE-M |
| Quantity | 120 units |
| Distribution | US Nationwide distribution in the state of New York. |
| Initiated | 2025-04-25 |
| Classified | 2025-06-13 |
| Recall number | Z-1976-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. (Z-1976-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96904/
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