CLASS III ONGOING Device recall · Reported 25 Jun 2025 · FDA Enforcement Report
AcoSound. Model Number: LW12-Bte recalled
Hangzhou Acosound Technology is recalling AcoSound. Model Number: LW12-Bte-m, distributed nationwide in the US. The recall was initiated on 25 Apr 2025 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1976-2025
- FDA event ID
- 96904
- Recalling firm
- Hangzhou Acosound Technology, Hangzhou, N/A
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 25 Apr 2025
- FDA classified
- 13 Jun 2025
- Reported
- 25 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 25 Apr 2025 | Recall initiated by company | |
| 13 Jun 2025 | Classified by FDA | +49 days |
| 25 Jun 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
AcoSound. Model Number: LW12-BTE-M
Where it was distributed
US Nationwide distribution in the state of New York.
Questions about this recall
Why was it 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.
Which lots are affected?
UDI: 06973375880000. Lot Number: Lot 001-120. Serial Numbers: SN110C30C580010802 to SN110C30C581200802
Where was it sold?
US Nationwide distribution in the state of New York.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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