The Recall Desk
ModerateFDA (Devices)·Z-1950-2026·Announced 2026-05-06

HiResolution Bionic Ear Battery Pak Fails Safety Door Compliance

Advanced Bionics is recalling HiResolution Bionic Ear System M Zn-Air Battery Paks because the non-tamperproof battery door does not require a tool to open, violating safety standards. The issue affects 45,173 units distributed worldwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II recall with no reported injuries or illnesses. The hazard is a standards-compliance issue involving a safety mechanism (tool-required battery access) that has not resulted in reported harm. This fits the Moderate category for a device safety defect where injury has not yet been reported.

Plain-English summary

Advanced Bionics, LLC is recalling the M Zn-Air Battery Pak, a disposable power source used with the Naida CI M and Sky CI M Sound Processors in the HiResolution Bionic Ear System. The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 because it does not require the use of a tool to replace the button/coin cell battery.

All lots manufactured up to February 3, 2026 are affected. The recalled product has been distributed nationwide throughout the United States and internationally to 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.

Patients using affected battery paks should contact Advanced Bionics for information about obtaining a replacement with a compliant battery door that requires a tool for opening.

The recalled product

Product
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
Manufacturer
Advanced Bionics, LLC
Category
Medical Device — Cochlear Implant Battery System
Hazard
  • safety-standards-non-compliance
  • tamper-resistance-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.

Related recalls

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