AcoSound Hearing Aid (AcoSound) – Labeling Error (2025)
Incorrect labeling may cause confusion about manufacturer information.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AcoSound. Model Number: LW12-BTE-M
Brand
HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. No.2 Building Room 401 No.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
UDI: 06973375880000. Lot Number: Lot 001-120. Serial Numbers: SN110C30C580010802 to SN110C30C581200802
HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. No.2 Building Room 401 No. is recalling AcoSound. Model Number: LW12-BTE-M due to Three issues 1. Label error: The manufacturer information in the labeling is not correct, the manufacturer's name is mislabeled as "Developed by AcoS. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026