FDA recall, , Moderate risk
HiResolution Bionic Ear System M Zn-Air Battery Pak
The M Zn-Air Battery Pak has a battery door that does not require a tool to replace the button/coin cell battery.
Summary by Recall Canary from the FDA notice
What happened
Advanced Bionics, LLC, of Valencia, California, recalled the HiResolution Bionic Ear System M Zn-Air Battery Pak because 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. The battery pak is a disposable power source for the Naida CI M and Sky CI M Sound Processors.
The recall began March 23, 2026, and was added to the FDA's Enforcement Report on April 27, 2026, with nationwide distribution in the U.S. and worldwide.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
- Model 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
- Lot code
- All lots manufactured up to February 3, 2026. Refer to Exhibit_0006
Recall details
- Company began the recall
- Sold in
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.
- Company
- Advanced Bionics, LLCValencia, California
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98678
- Recall number
- Z-1950-2026
All recalls from Advanced Bionics, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
