Lynge, Denmark
Widex A/S recalls
1 recall recorded since 2018, most recently on 31 August 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 31 August 2018
- Terminated
- 21 December 2018
- Reason
- 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.
- Distribution
- US Distribution to states of: GA and NY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0094-2019
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.