Z-1976-2025Class III

AcoSound. Model Number: LW12-BTE-M

Name: Z-1976-2025 AcoSound. Model Number: LW12-BTE-M
Creator: Hangzhou Acosound Technology Co., Ltd.
Published: 2025-04-25
License: https://open.fda.gov/license/

Hangzhou Acosound Technology Co., Ltd. / initiated 2025-04-25 / Open, Classified / root cause: labeling and UDI

FDA source

HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. began a recall of AcoSound. Model Number: LW12-BTE-M on 2025-04-25. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1976-2025
Classification: Class III
Status: Open, Classified
Initiated: 2025-04-25
Posted: 2025-06-13
Recalling firm: Hangzhou Acosound Technology Co., Ltd.
Product: AcoSound. Model Number: LW12-BTE-M
Product code: QUG Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 120 units
Distribution: US Nationwide distribution in the state of New York.
Product codes and lots: UDI: 06973375880000. Lot Number: Lot 001-120. Serial Numbers: SN110C30C580010802 to SN110C30C581200802

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1976-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1976-2025	Class III	Ongoing	Voluntary: Firm initiated	2025-06-25	2025-06-13

Product code QUG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)