Official recall notice
FDA DeviceClass IINotable
FDA Recall: Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Mode
- Recall date
- 2026-06-10
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Due to incorrect shelf-life expiration date.
Recommended action
What to do
36
Product description
Due to incorrect shelf-life expiration date.