Class III — Advanced Bionics, LLC
| Recalling firm | Advanced Bionics LLC |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated. |
| Product | AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Nada CI Q90 Sound Processor (CI-5280), Nada CI Q70 Sound Processor (CI-5245) and Nada CI Q30 Sound Processor (CI-5260) for cochlear implant. |
| Quantity | 53 units |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of NY, IL, MA, NE, CA, HI, LA, MS, AL, FL, SC, OH and the countries of Belgium, Germany, Italy Netherlands, Spain, Colombia, Czech Republic, Iran, Kuwait, Panama, Peru, Taiwan, Italy. |
| Initiated | 2020-09-26 |
| Classified | 2020-11-25 |
| Terminated | 2023-05-04 |
| Recall number | Z-0486-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Advanced Bionics, LLC (Z-0486-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86536/
Alerts for Advanced Bionics LLC
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.