CLASS II Device recall · Reported 17 Oct 2018 · FDA Enforcement Report
BABY hearing aid (referred to as BABY440) recalled by Widex A/S
Widex is recalling BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10, distributed in Georgia, New York. The recall was initiated on 31 Aug 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0094-2019
- FDA event ID
- 81085
- Recalling firm
- Widex, Lynge
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Aug 2018
- FDA classified
- 10 Oct 2018
- Reported
- 17 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Hearing Aids
Timeline
| 31 Aug 2018 | Recall initiated by company | |
| 10 Oct 2018 | Classified by FDA | +40 days |
| 17 Oct 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US Distribution to states of: GA and NY.
Questions about this recall
Why was it 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.
Which lots are affected?
Serial numbers 024569 and 024550
Where was it sold?
US Distribution to states of: GA and NY.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Hearing Aids recalls
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits: Discectomy Pack DYNJ86476B Ear recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | See RES for full list recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | HiResolution" Bionic Ear System M Zn-Air Battery Pak recalled | Advanced Bionics | Device Malfunction | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Chp Cochlear Supplement Cds recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline medical procedure convenience kits labeled as recalled | Medline Industries | Device Malfunction | Nationwide |