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U.S. Department of Health and Human Services

Class 3 Device Recall AcoSound

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 Class 3 Device Recall AcoSoundsee related information
Date Initiated by FirmApril 25, 2025
Date PostedJune 13, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1976-2025
Recall Event ID 96904
Product Classification Hearing Aid, Air-Conduction with Wireless Technology, Over the Counter - Product Code QUG
ProductAcoSound. Model Number: LW12-BTE-M
Code Information UDI: 06973375880000. Lot Number: Lot 001-120. Serial Numbers: SN110C30C580010802 to SN110C30C581200802
Recalling Firm/
Manufacturer		 HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.
No.2 Building Room 401
No. 1390 Cangxing Street, Yuhang
Hangzhou China
Manufacturer 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.
FDA Determined
Cause 2		Labeling design
ActionThe firm notified its single consignee/importer on about 04/25/2025 via email. The notification instructed the importer to examine inventory and arrange for replacement labels. The importer notified their consignees from 05/01-20/2025 of the recall via email or telephone. They instructed their customers that that the product label needs to be updated and provided the arrangement for replacing the label.
Quantity in Commerce120 units
DistributionUS Nationwide distribution in the state of New York.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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