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Open, Classified

AcoSound. Model Number: LW12-BTE-M

FDA Recall Z-1976-2025 · Posted 2025-06-13

Recalling FirmHANGZHOU ACOSOUND TECHNOLOGY CO., LTD.
Recall StatusOpen, Classified
Product CodeQUG
Date Initiated2025-04-25
Product Quantity120 units

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.

Firm Action

The 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.

Root Cause

Labeling design

Distribution Pattern

US Nationwide distribution in the state of New York.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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