Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86536

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 26, 2020
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Advanced Bionics, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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.

Z-0486-2021
Recall number
Z-0486-2021
Initiated
September 26, 2020
Classification
Class III
Status
Terminated
Recalling firm
Advanced Bionics, LLC
Quantity
53 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Mislabeling

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.

Code information

410079020

Distribution pattern

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.

device · product 2 of 2

AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 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.

Z-0487-2021
Recall number
Z-0487-2021
Initiated
September 26, 2020
Classification
Class III
Status
Terminated
Recalling firm
Advanced Bionics, LLC
Quantity
28 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Mislabeling

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.

Code information

410078519

Distribution pattern

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.