FDA Medical Device Recalls (openFDA)
HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.: AcoSound. Model Number: LW12-BTE-M
- Recall number
- Z-1976-2025
- Recalling firm
- HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.
- Product
- AcoSound. Model Number: LW12-BTE-M
- Status
- Open, Classified
- Initiated
- 2025-04-25
- Posted
- 2025-06-13
- Terminated
- not on file
- 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.
- Root cause
- Labeling design
- Action
- The firm notified its single consignee/importer on about 04/25/2025 via email. The notification instructed the importer to examine inventory and arrange for replacement labels. The importer notified their consignees from 05/01-20/2025 of the recall via email or telephone. They instructed their customers that that the product label needs to be updated and provided the arrangement for replacing the label.
- Quantity
- 120 units
- Distribution
- US Nationwide distribution in the state of New York.
- Lot, serial or model codes
- UDI: 06973375880000. Lot Number: Lot 001-120. Serial Numbers: SN110C30C580010802 to SN110C30C581200802
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QUG
- Firm FEI
- 3011350813
- Firm city
- Hangzhou
- Firm state
- not on file
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28