🔍 RecallPedia

AcoSound. Model Number: LW12-BTE-M

Class I - Dangerous
🏥 Medical Devices Recalled: April 25, 2025 HANGZHOU ACOSOUND TECHNOLOGY CO. Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI: 06973375880000. Lot Number: Lot 001-120. Serial Numbers: SN110C30C580010802 to SN110C30C581200802
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

AcoSound. Model Number: LW12-BTE-M

Product Codes/Lot Numbers:

UDI: 06973375880000. Lot Number: Lot 001-120. Serial Numbers: SN110C30C580010802 to SN110C30C581200802

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1976-2025