FDA Device recall Z-1976-2025
AcoSound
- FDA Device
- Class III
- ongoing
- Published 2025-06-25
On 2025-06-25 the FDA classified a Class III recall of AcoSound by Hangzhou Acosound Technology, citing 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 "Manu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1976-2025 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-04-25 |
| Published | 2025-06-25 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Hangzhou Acosound Technology |
| Distribution | US |
Product
AcoSound. Model Number: LW12-BTE-M
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.
Identifiers
| code_info | UDI: 06973375880000. Lot Number: Lot 001-120. Serial Numbers: SN110C30C580010802 to SN110C30C581200802 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1976-2025%22
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