Recall Z-1976-2025— HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.
Class III · Ongoing
Class III FDA medical device recall by HANGZHOU ACOSOUND TECHNOLOGY CO., LTD., initiated 2025-04-25. FDA's recall record names no specific 510(k) clearance for this event. Product: AcoSound. Model Number: LW12-BTE-M. Reason: 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..
- Recalling firm
- HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2025-04-25
- Firm location
- Hangzhou, N/A, China
Product description
AcoSound. Model Number: LW12-BTE-M
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.