The Recall Desk
ModerateFDA (Devices)·Z-0486-2021·Announced 2020-12-02

Advanced Bionics Recalls Mislabelled PowerCel 230 Cochlear Implant Batteries

Advanced Bionics is recalling 53 PowerCel 230 batteries for cochlear implants because they may be mislabeled with incorrect battery life information.

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: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The hazard is a labeling error regarding battery life, which fits the rubric criteria for minor labeling errors.

Plain-English summary

Advanced Bionics, LLC is recalling 53 units of the AB PowerCel 230 (velvet black) batteries, reference CI-5523-150. These batteries are used to power the Naida CI Q90, Q70, and Q30 Sound Processors for cochlear implants.

The recall was initiated because it was determined that some of the batteries were improperly labeled and may contain a different battery life than indicated on the packaging. The affected units were distributed worldwide, including nationwide in the United States and in various international locations.

Consumers who possess these specific batteries should stop using them and contact Advanced Bionics for instructions on how to proceed. The recall is limited to the specific reference number and UDI listed in the agency documentation.

The recalled product

Product
AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Na¿da CI Q90 Sound Processor (CI-5280), Na¿da CI Q70 Sound Processor (CI-5245) and Na¿da CI Q30 Sound Processor (CI-5260) for cochlear implant.
Affected units
53

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 (1)

  • 410079020

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Advanced Bionics, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →