Widex BABY Hearing Aids Recalled for Non-Tamper-Resistant Battery Drawers
Widex A/S is recalling two BABY440 hearing aids because they were fitted with non-tamper-resistant battery drawers. The devices were distributed in Georgia and New York.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (hearing aid for infants) where the defect (non-tamper-resistant battery drawer) poses a safety risk, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Widex A/S is recalling two units of the Widex BABY hearing aid, also known as the BABY440. These devices are intended for babies aged 0 to 3 years and use size 10 zinc-air batteries. The specific units affected have serial numbers 024569 and 024550.
The recall is due to the mounting of a non-tamper-resistant, or ordinary, battery drawer on these specific hearing aids. The correct battery drawer is designed to be tamper-resistant and requires a special tool to open. The use of the incorrect drawer creates a potential safety hazard for the intended users.
The affected devices were distributed in the United States to the states of Georgia and New York. Consumers who possess these specific serial numbers should contact Widex A/S for instructions on how to resolve the issue.
The recalled product
- Product
- Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is intended for, but not limited to, babies (0 to 3 years of age) to be used as air conduction amplification devices in everyday listening environments.
- Manufacturer
- Widex A/S
- Category
- Medical Device — Hearing Aids
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial numbers 024569 and 024550
Distribution
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