Widex BABY hearing aid recall
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…
Why was Widex BABY hearing aid recalled?
The reason for this field action is due to the mounting of a non-tamper-resistant (ordinary) battery drawer on some BABY440 hearing aids. The correct battery drawer is tamper-resistant and require a special tool to open it.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial numbers 024569 and 024550
- 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…
- Recalling firm
- Widex A/S
- Quantity
- 2
- Distribution
- US Distribution to states of: GA and NY.
- Recall date
- October 17, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)