Advanced Bionics, LLC recalls Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor
- Recalling company
- Advanced Bionics, LLC
- Product
- Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
- Reason
- Behind-the-ear sound processer packaging label is different then included product.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Nov 27, 2025
- Reported
- Mar 11, 2026
- Distribution
- Unknown
- Status
- Ongoing
- Quantity
- 2 units
- Lot / codes
- Lot Code: UDI-DI: 08400944CI5295YJ Model Number: CI-5295-150 Serial Numbers: 249596, 249603
- Company location
- Valencia, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1493-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1493-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.