Official recall record

AcoSound. Model Number: LW12-BTE-M

US FDA — Medical Devices · 2025-04-25 · ChinaClass III

Issuing authority: US FDA — Medical Devices
Alert date: 2025-04-25
Country of alert: China
Alert level: Class III
Alert type: recall
Barcode (EAN/GTIN): 06973375880000
Brand on record: HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.

What the authority reported

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

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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