FDA recall, , Moderate risk
Advanced Bionics HiResolution Bionic Ear System Cochlear Implants
The HiResolution Bionic Ear System has an incorrect shelf-life expiration date.
Summary by Recall Canary from the FDA notice
What happened
Advanced Bionics, LLC of Valencia, California recalled the HiResolution Bionic Ear System, specifically the HiRes Ultra 3D CI with the HiFocus Mid Scala electrode, due to an incorrect shelf-life expiration date. The recall began on April 30, 2026, and was added to the FDA's Enforcement Report on June 1, 2026.
The product was distributed nationwide in states including California, Colorado, Georgia, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Missouri, Montana, North Carolina, Tennessee, Washington, and Wisconsin.
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?
Match the model number and lot code listed under your product.
- Model number
- CI-1601-04
- Lot code
- 2225141
- 2225150
- 2225152
- 2225155
- 2225160
- 2225188
- 2227161
- 2229827
- 2229839
- 2229849
- 2214172
- 2225146
- 2225154
- 2225168
- 2225189
- 2226476
- 2227006
- 2227007
- 2227012
- 2227038
- 2227071
- 2227112
- 2227122
- 2227129
- 2227148
- 2227151
- 2227183
- 2227196
- 2227202
- 2227207
- 2227212
- 2227215
- 2227220
- 2227235
- 2229803
- 2229836
Recall details
- Company began the recall
- Sold in
U.S. Nationwide distribution in the states of California, Colorado, Georgia, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Missouri, Montana, North Carolina, Tennessee, Washington and Wisconsin.
- Company
- Advanced Bionics, LLCValencia, California
- Hazard
- Labeling error
- 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
- 98916
- Recall number
- Z-2283-2026
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
