HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.: Medical Device Recall in 2025 - (Recall #: Z-1976-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

AcoSound. Model Number: LW12-BTE-M

Product Classification:

Class III

Date Initiated: April 25, 2025

Date Posted: June 25, 2025

Recall Number: Z-1976-2025

Event ID: 96904

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.

Status: Ongoing

Product Quantity: 120 units

Code Information:

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

Distribution Pattern:

US Nationwide distribution in the state of New York.

Voluntary or Mandated:

Voluntary: Firm initiated