AcoSound. Model Number: LW12-BTE-M
Published June 25, 2025 · Recall initiated: April 25, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.
- Distributor
- US Nationwide distribution in the state of New York.
- Lot
- UDI: 06973375880000. Lot Number: Lot 001-120. Serial Numbers: SN110C30C580010802 to SN110C30C581200802
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- China
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