Hearing Aid Labeling Error and UDI Non-Compliance Recall
AcoSound hearing aid models are being recalled due to labeling errors and incomplete UDI (Unique Device Identification) information. Affected units have incorrect manufacturer information and missing required compliance documentation.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recalls are typically scored as 1 or 2. This recall involves labeling errors and incomplete UDI documentation, which constitute compliance violations without reported harm or functional defect, justifying a Moderate severity rating.
Plain-English summary
AcoSound Model LW12-BTE-M hearing aids (120 units) are being recalled by the manufacturer due to labeling and labeling compliance issues. The devices have incorrect manufacturer attribution and incomplete Unique Device Identification (UDI) information on their labeling.
The specific issues are: (1) the manufacturer name is mislabeled as 'Developed by AcoSound' instead of the correct 'Manufactured by Hangzhou AcoSound,' and the labeling lacks a required statement of the manufacturer's place of business; (2) a customer named 'Blaid' is incorrectly marked on the labeling in a way that suggests they are the manufacturer; and (3) the UDI information is incomplete, lacking required DI (Device Identifier) and correct PI (Product Identifier) information, and does not comply with FDA UDI labeling requirements.
The recalled devices were distributed nationwide in the state of New York and are identified by Lot Number 001-120 and Serial Numbers SN110C30C580010802 to SN110C30C581200802. This is a Class III recall. Consumers who have received these devices should contact the manufacturer for information about corrected labeling or device replacement.
The recalled product
- Product
- AcoSound. Model Number: LW12-BTE-M
- Manufacturer
- HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.
- Category
- Medical Device — Hearing Aid
- Hazard
- mislabeling
- missing-manufacturer-address
- udi-non-compliance
Distribution
Distributed nationwide across the United States.
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