Home / Recalls / Advanced Bionics, LLC / Z-1950-2026

Z-1950-2026 Class II Ongoing

Recalled by Advanced Bionics, LLC — Valencia, CA

Recall Details

Product Type
Devices
Report Date
May 6, 2026
Initiation Date
March 23, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
45173

Product Description

Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; CI-5501-240; CI-5501-250; CI-5501-260; CI-5501-270; CI-5501-280 Software Version: Not Applicable Product Description: The M Zn-Air Battery Pak is a disposable power source for the Naida" CI M and Sky CI" M Sound Processors. The type of disposable battery to be used with the M Zn-Air Battery Pak is a 675 power implant battery (P675). Regular 675 hearing instrument batteries will not be powerful enough for a cochlear implant. The suggested manufacturer and battery is PowerOne P675 Implant Plus battery. The M Zn-Air Battery Pak is available with non-tamperproof and tamperproof cartridges. Component: Not Applicable

Reason for Recall

The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell battery.

Distribution Pattern

Worldwide - U.S Nationwide distribution including in the state of AK, AL, AR, AZ, CA, CO, CT, CD, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Canada, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, China, Chile, Croatia, Cuba, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Guam, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kazakhstan, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Trinidad and Tobago, United Arab Emirates, and United Kingdom.

Code Information

Lot Code: All lots manufactured up to February 3, 2026. Refer to Exhibit_0006

Other recalls by Advanced Bionics, LLC

  • Z-2283-2026 Class II — Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiF (April 30, 2026)
  • Z-1493-2026 Class II — Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Proce (November 27, 2025)
  • Z-1813-2025 Class II — HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607 (March 5, 2025)
  • Z-0486-2021 Class III — AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used (September 26, 2020)
  • Z-0487-2021 Class III — AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 used (September 26, 2020)
  • Z-2033-2020 Class II — AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: (February 17, 2020)
  • Z-2032-2020 Class II — AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - (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-1084-2019 Class II — Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model (February 6, 2019)