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HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. recalls AcoSound. Model Number: LW12-BTE-M
Recalled June 25, 2025 · FDA recall Z-1976-2025 · HANGZHOU ACOSOUND TECHNOLOGY
Hazard
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 Class III
Units
120 units
Sold at
US Nationwide distribution in the state of New York.
Description
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.
Product
AcoSound. Model Number: LW12-BTE-M
Manufacturer(s)
HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.
Made in
China
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →