PlainRecalls

Advanced Bionics, LLC

Compiled from official public sources by the publisher.

13 recalls on record · Latest: Jun 10, 2026

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Agency notice ledger

Federal filing book Advanced Bionics, LLC LIGHT-BOOK · SINGLE-AGENCY

#1,146 of 14,151 · 13 notices · 0.012% archive

  • BOOK 13 notices
  • RANK #1,146 of 14,151
  • SHARE 0.012% archive
  • AGENCY FDA Devices (13)
  • CAT medical devices
  • CATS 1 category
  • LATEST Jun 10, 2026
  • PHOTO Aequita Pharmacy

Nearest notice-volume peer: Aequita Pharmacy (0 notice gap)

Advanced Bionics, LLC accounts for about 0.012% of the 104,423-notice archive on 13 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Where Advanced Bionics, LLC sits among 14,151 recalling firms

Advanced Bionics, LLC ranks 1,146th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Advanced Bionics, LLC vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

13 1146th of 14151 higher than 12,927 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Advanced Bionics, LLC in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Advanced Bionics, LLC holds about 0.012% of archive notices alongside 13 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Jun 10, 2026

Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1601-04 Software Version: N/A Product Description: The HiResolution Bionic Ear System is a cochlear implant designed to provide useful hearing to individuals with severe-to-profound hearing loss. It consists of internal and external components. The internal components include the HiRes" Ultra 3D receiver and either the HiFocus" SlimJ electrode or the HiFocus" Mid-Scala (MS)

FDA Devices Moderate May 6, 2026

Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; CI-5501-240; CI-5501-250; CI-5501-260; CI-5501-270; CI-5501-280 Software Version: Not Applicable Product Description: The M Zn-Air Battery Pak is a disposable power source for the Naida" CI M and Sky CI" M Sound Processors. The type of disposable battery to be used with the M Zn-Air Battery Pak is a 675 power implan
FDA Devices Moderate Mar 11, 2026

Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
FDA Devices Moderate May 28, 2025

HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
FDA Devices Low Dec 2, 2020

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.
FDA Devices Low Dec 2, 2020

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.
FDA Devices Moderate May 27, 2020

AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
FDA Devices Moderate May 27, 2020

AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
FDA Devices Low Mar 11, 2020

SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWave Professional Suite 3.2, CE 0123 - Product Usage: Soundwave 3.2 is used by healthcare professionals to program Advanced Bionics sound processors for use with Advanced Bionics cochlear implants, a device is intended to restore a level of auditory sensation to children with profound sensorineural deafness via electrical stimulation of the auditory nerve.
FDA Devices Low Feb 26, 2020

HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
FDA Devices Moderate Apr 10, 2019

Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.
FDA Devices Moderate Apr 10, 2019

Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.
FDA Devices Moderate Apr 10, 2019

Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.

Advanced Bionics, LLC holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (13 here — thin-book).

Aequita Pharmacy 13 Alden Optical 13 Amneal Pharmaceuticals, LLC 13 Ani Pharmaceuticals, Inc. 13 AtriCure, Inc. 13

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Aequita Pharmacy 13 Alden Optical 13 AtriCure, Inc. 13 Augustine Temperature Management, LLC 13

Frequently Asked Questions

How many federal recall notices name Advanced Bionics, LLC? ▼
PlainRecalls indexes 13 distinct federal recall events naming Advanced Bionics, LLC, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Advanced Bionics, LLC sit among other recalling firms? ▼
Advanced Bionics, LLC ranks #1,146 of 14,151 by distinct recall-event count among 14,151 firms in this archive (91st percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Advanced Bionics, LLC's notices? ▼
FDA Devices accounts for 13 of this firm's 13 indexed notices.
What product category dominates Advanced Bionics, LLC's filing book? ▼
Filings for Advanced Bionics, LLC span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Advanced Bionics, LLC: 13 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Advanced Bionics, LLC; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026