Reported Jun 25, 2025 · Ongoing

AcoSound. Model Number: LW12-BTE-M

Hangzhou Acosound Technology Co., Ltd.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. · No.2 Building Room 401 · Hangzhou, N/A · N/A

Is this the product you have?

  • AcoSound
  • Model NumberLW12-BTE-M
Lot codes and dates
  • UDI06973375880000
  • Lot NumberLot 001-120
  • Serial NumbersSN110C30C580010802 to SN110C30C581200802
Amount recalled
120 units

Where it was sold

  • Nationwide
  • NY

Why it was 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.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Hangzhou Acosound Technology Co., Ltd. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:17 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.