Medical Device Recall: AcoSound. Model Number: LW12-BTE-M
HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. · April 25, 2025
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.
Distribution
US Nationwide distribution in the state of New York.
States Affected
NATIONWIDE
Quantity Affected
120 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1976-2025
Status: ongoing
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