AcoSound — Class III medical device recall Z-1976-2025
Ongoing recall by HANGZHOU ACOSOUND TECHNOLOGY CO., LTD., reported 2025-06-25, distributed nationwide. Three issues 1. Label error: The manufacturer information in the labeling is not correct, the manufacturer's n
| Recall number | Z-1976-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | HANGZHOU ACOSOUND TECHNOLOGY CO., LTD., Hangzhou, N/A, China |
| Recall initiated | 2025-04-25 |
| Classified | 2025-06-13 |
| Reported by FDA | 2025-06-25 |
| Distributed | Nationwide (US) |
| Quantity | 120 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 06973375880000 |
| Lot numbers | 001-120 |
| Serial numbers | SN110C30C580010802, SN110C30C581200802 |
| Model numbers | LW12-BTE-M |
Product
AcoSound. Model Number: LW12-BTE-M
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1976-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.