AcoSound. Model Number: LW12-BTE-M recallZ-1976-2025 · Hangzhou Acosound Technology CO., Ltd. · initiated Apr 25, 2025
Class III Open, Classified All recalls posted in June 2025
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hangzhou Acosound Technology CO., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling design
What the company is doing
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.
Recall details
- Recall number
- Z-1976-2025
- Recall class
- Class III
- Status
- Open, Classified
- Initiated by the company
- Apr 25, 2025
- Posted by the FDA
- Jun 13, 2025
- Recalling firm
- Hangzhou Acosound Technology CO., Ltd.
- Quantity
- 120 units
- Product code
- QUG
- Distribution
- US Nationwide distribution in the state of New York.
Product description
AcoSound. Model Number: LW12-BTE-M
Code information (models, lots, serial numbers)
UDI: 06973375880000. Lot Number: Lot 001-120. Serial Numbers: SN110C30C580010802 to SN110C30C581200802
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ACOSOUND Leya-W- BTE-MHangzhou AcoSound Technology Co.,Ltd. · Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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