FDA Medical Device Recalls (openFDA)
Advanced Bionics, LLC: Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
- Recall number
- Z-1493-2026
- Recalling firm
- Advanced Bionics, LLC
- Product
- Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
- Status
- Open, Classified
- Initiated
- 2025-11-27
- Posted
- 2026-03-05
- Terminated
- not on file
- Reason
- Behind-the-ear sound processer packaging label is different then included product.
- Root cause
- Under Investigation by firm
- Action
- On November 27, 2025, Advanced Bionics issued a recall notification to affected consignees via Email. Advanced Bionics ask consignees to take the following actions: Consignees to contact UK customer service to initiate the exchange of the mislabeled product with the correct product. Acknowledge receipt and understanding of the recall communication.
- Quantity
- 2 units
- Distribution
- Unknown
- Lot, serial or model codes
- Lot Code: UDI-DI: 08400944CI5295YJ Model Number: CI-5295-150 Serial Numbers: 249596, 249603
- 510(k) numbers
- not on file
- PMA numbers
- ["P960058S149"]
- Product code
- MCM
- Firm FEI
- 1000220815
- Firm city
- Valencia
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28