Use cautionMedical device recall · FDA · Published March 23, 2026
HiResolution Bionic Ear System Battery Pak: Non-Tamperproof Door May Not Require Tool
HiResolution recalls M Zn-Air Battery Paks (models CI-5501-110 to CI-5501-280) due to non-tamperproof battery door that may not require tool to replace battery, risking improper installation.
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.
Take action
Contact the company
📍Recalling firmAdvanced Bionics, LLC28515 Westinghouse Pl · Valencia, CA 91355-1398
“HiResolution Bionic Ear System Battery Pak: Non-Tamperproof Door May Not Require Tool.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49648-hiresolution-bionic-ear-system-battery-pak-non-tamperproof-door-may. Based on FDA recall #Z-1950-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1950-2026%22&limit=1).
The FDA announced on March 23, 2026, that Advanced Bionics, LLC is voluntarily recalling HiResolution M Zn-Air Battery Pak units due to a non-tamperproof battery door. The hazard involves the failure to require a tool for battery replacement. Owners should contact the company for remedy details.
Lot Code: All lots manufactured up to February 3, 2026
The hazard
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.
Context
GovInfoNow's records show Advanced Bionics, LLC has 8 other recalls on record since February 6, 2019. Other recent recalls include HiResolution Bionic Ear System Recall regarding incorrect shelf-life expiration date (April 30, 2026) and HiResolution Sky CI M90 Sound Processor Recall for packaging label mismatch (November 27, 2025).
How to tell if you have this one
Check for the model numbers CI-5501-110 through CI-5501-280 on the battery pack. The product is sold with non-tamperproof cartridges and was manufactured up to February 3, 2026.
Brand
HiResolution
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Battery Pack Model
Identify the model number on the battery pack to confirm if it's in the recalled range (CI-5501-110 to CI-5501-280).
Use Correct Tool for Replacement
If you have a recalled battery pack, use the proper tool to replace the battery to ensure safe installation.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 50 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 44 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1950-2026 (March 23, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1950-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.