FDA Medical Device Recalls (openFDA)
Widex A/S: 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.
- Recall number
- Z-0094-2019
- Recalling firm
- Widex A/S
- 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.
- Status
- Terminated
- Initiated
- 2018-08-31
- Posted
- not on file
- Terminated
- 2018-12-21
- 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.
- Root cause
- Employee error
- Action
- The firm, Widex, sent an "Urgent Medical Device Correction Letter" dated 8/28/18 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: a) Investigate, whether your childs BABY440 hearing aid is mounted with the correct battery drawer. Please refer to the attachment How to determine if correct battery drawer is mounted. b) If affirmative, return the product to the hearing care professional, where you bought the hearing aid, to have the tamper-resistant battery drawer mounted. If you have any questions, contact Director, Global Regulatory Affairs at 0045 44 35 57 71 or email to: krpe@widex.com.
- Quantity
- 2
- Distribution
- US Distribution to states of: GA and NY.
- Lot, serial or model codes
- Serial numbers 024569 and 024550
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ESD
- Firm FEI
- 3003557127
- Firm city
- Lynge
- Firm state
- not on file
- Firm country
- Denmark
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28