Recall Register

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Advanced Bionics, LLC

FDA recalling firm · 9 enforcement events · 13 product records · 2019–2026 · CA

Advanced Bionics, LLC has 9 FDA enforcement events on this register (13 product records) between 2019 and 2026: 9 device; the busiest year was 2019 with 3.

0% of its events are Class I; the most common class is Class II (6). 4 events are listed as ongoing; the recalling firm's address is in CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
30 Apr 2026Brand 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…DeviceClass II1Ongoing
23 Mar 2026Brand 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…DeviceClass II1Ongoing
27 Nov 2025Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150DeviceClass II1Ongoing
5 Mar 2025HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607DeviceClass II1Ongoing
26 Sep 2020AB 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.DeviceClass III2Terminated
17 Feb 2020AB 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.DeviceClass II2Terminated
4 Apr 2019SoundWave 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…DeviceClass III1Terminated
18 Mar 2019HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.DeviceClass III1Terminated
6 Feb 2019Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.DeviceClass II3Terminated

By type and class

Device9
Class II6
Class III3

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

19
20
21
22
23
24
25
26
Enforcement events for Advanced Bionics, LLC by year initiated.

Questions and answers

How many FDA recalls has Advanced Bionics, LLC had?

9 enforcement events (13 product records) on this register, 2019–2026: 9 device.

Are any Advanced Bionics, LLC recalls ongoing?

4 events are listed as ongoing in the current openFDA export.

What class are Advanced Bionics, LLC recalls?

6 Class II, 3 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.