FDA Medical devices recall ·
AcoSound recall
- Recall number
- Z-1976-2025
- Date
- (initiated April 25, 2025)
- Company / brand
- Hangzhou Acosound Technology CO., Ltd.
No.2 Building Room 401, Hangzhou, N/A, China - Category
- Medical devices › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 120 units
- Hazard tags
- Mislabeling
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
AcoSound. Model Number: LW12-BTE-M
Why was it 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 you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI: 06973375880000. Lot Number: Lot 001-120. Serial Numbers: SN110C30C580010802 to SN110C30C581200802
Distribution
US Nationwide distribution in the state of New York.
States: New York
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (medical devices), recall Z-1976-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.