Reported Jun 25, 2025 · Ongoing
AcoSound. Model Number: LW12-BTE-M
Hangzhou Acosound Technology Co., Ltd.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. · No.2 Building Room 401 · Hangzhou, N/A · N/A
Is this the product you have?
- AcoSound
- Model NumberLW12-BTE-M
- Lot codes and dates
- UDI06973375880000
- Lot NumberLot 001-120
- Serial NumbersSN110C30C580010802 to SN110C30C581200802
- Amount recalled
- 120 units
Where it was sold
- Nationwide
- NY
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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