FDAApril 25, 2025device

AcoSound. Model Number: LW12-BTE-M

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

hangzhou acosound technologyhangzhouhangzhou acosound

UPCs

06973375880000

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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