Summary
The FDA issued a Class III for AcoSound. Model Number: LW12-BTE-M by HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.. Reason: Three issues 1. Label error: The manufacturer information in the labeling is not correct, the manufacturer's name is mislabeled as "Developed by Aco.
Details
Source
Device Recall
External ID
Z-1976-2025
Action Date
2025-06-25
Status
Ongoing
Category
device
Product Description
AcoSound. Model Number: LW12-BTE-M
Lot/Code Info: UDI: 06973375880000. Lot Number: Lot 001-120. Serial Numbers: SN110C30C580010802 to SN110C30C581200802
Quantity Affected: 120 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.
Distribution
US Nationwide distribution in the state of New York.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-25
Company
Hangzhou, N/A
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 167 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. have FDA actions?
This is the only FDA action we have on record for HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1976-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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