Home / Recalls / Advanced Bionics, LLC / Z-1493-2026

Z-1493-2026 Class II Ongoing

Recalled by Advanced Bionics, LLC — Valencia, CA

Recall Details

Product Type
Devices
Report Date
March 11, 2026
Initiation Date
November 27, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 units

Product Description

Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150

Reason for Recall

Behind-the-ear sound processer packaging label is different then included product.

Distribution Pattern

Unknown

Code Information

Lot Code: UDI-DI: 08400944CI5295YJ Model Number: CI-5295-150 Serial Numbers: 249596, 249603

Other recalls by Advanced Bionics, LLC

  • Z-1813-2025 Class II — HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607 (March 5, 2025)
  • Z-0487-2021 Class III — AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 used (September 26, 2020)
  • Z-0486-2021 Class III — AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used (September 26, 2020)
  • Z-2032-2020 Class II — AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - (February 17, 2020)
  • Z-2033-2020 Class II — AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: (February 17, 2020)
  • Z-1441-2020 Class III — SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, U (April 4, 2019)
  • Z-1259-2020 Class III — HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF C (March 18, 2019)
  • Z-1085-2019 Class II — Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140. (February 6, 2019)
  • Z-1083-2019 Class II — Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model (February 6, 2019)
  • Z-1084-2019 Class II — Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model (February 6, 2019)