# FDA recall Z-1976-2025

> **HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.** · Class III · device recall initiated 2025-04-25.

## Product

AcoSound. Model Number: LW12-BTE-M

## 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.

## Key facts

- **Recall number:** Z-1976-2025
- **Recalling firm:** HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-04-25
- **Report date:** 2025-06-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hangzhou, N/A, China

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1976-2025

## Citation

> AI Analytics. FDA recall Z-1976-2025. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-1976-2025. Source: US FDA. Licensed CC0.

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