Drug recall
AcoSound. Model Number: LW12-BTE-M
FDA recall event 96904 · Class III · HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.
Key facts
| Event ID | 96904 |
|---|---|
| Recall numbers | Z-1976-2025 |
| Recalling firm | HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. |
| Product type | Devices |
| Products | AcoSound. Model Number: LW12-BTE-M |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Apr 25, 2025 |
| Report date | Jun 25, 2025 |
| City | Hangzhou |
| Country | China |
| FEI number | 3011350813 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: