Official recall notice
FDA DeviceClass IINotable
FDA Recall: Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog
- Recall date
- 2026-03-11
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Behind-the-ear sound processer packaging label is different then included product.
Recommended action
What to do
2 units
Product description
Behind-the-ear sound processer packaging label is different then included product.