FDA Medical devices recall ·
HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor… recall
- Recall number
- Z-1493-2026
- Date
- (initiated November 27, 2025)
- Company / brand
- Advanced Bionics, LLC
28515 Westinghouse Pl, Valencia, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Why was it recalled?
Behind-the-ear sound processer packaging label is different then included product.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: UDI-DI: 08400944CI5295YJ Model Number: CI-5295-150 Serial Numbers: 249596, 249603
Distribution
Unknown
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1493-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.