FDAHealthNovember 27, 2025
Advanced Bionics, LLC — Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
⚠️ Behind-the-ear sound processer packaging label is different then included product.
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- November 27, 2025
Unknown
What's affected?
- Product
- Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
- Lot code
- UDI-DI:
Additional details
Lot Code: UDI-DI: 08400944CI5295YJ Model Number: CI-5295-150 Serial Numbers: 249596, 249603
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2 units.
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