AcoSound recalled over labeling errors

Recall date

April 25, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. recalls AcoSound. Model Number: LW12-BTE-M

Recall number

Z-1976-2025

FDA classification

Class III

Brand / firm

HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.

Sold / distributed

US Nationwide distribution in the state of New York.

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

AcoSound. Model Number: LW12-BTE-M