AcoSound recall: Labeling Error
AcoSound. Model Number: LW12-BTE-M
Why was AcoSound recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 06973375880000. Lot Number: Lot 001-120. Serial Numbers: SN110C30C580010802 to SN110C30C581200802
- Product
- AcoSound. Model Number: LW12-BTE-M
- Recalling firm
- HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.
- Quantity
- 120 units
- Distribution
- US Nationwide distribution in the state of New York.
- Recall date
- June 25, 2025
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)