CLASS II Device recall · Reported 27 May 2020 · FDA Enforcement Report
AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode recalled
Advanced Bionics is recalling AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode, distributed nationwide in the US. The recall was initiated on 17 Feb 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2033-2020
- FDA event ID
- 85141
- Recalling firm
- Advanced Bionics, Valencia, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Feb 2020
- FDA classified
- 15 May 2020
- Reported
- 27 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 17 Feb 2020 | Recall initiated by company | |
| 15 May 2020 | Classified by FDA | +88 days |
| 27 May 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
hearing performance degradation due to body-fluid entering the device.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - US Nationwide distribution and the countries of Canada, Brazil, Bangladesh, Switzerland, China, Australia, India, South Korea, Thailand, Ecuador, Mexico, El Salvador, Guatemala, Malaysia, Myanmar, Taiwan, Chile, Costa Rica, Colombia, Panama, Japan, Argentina, Peru, Singapore, China, New Zealand, Vietnam, Dominican Republic Refer to uploaded consignee lists in Associated Documents: Exhibit 05_ConsigneeList_Center_17FEB2020 Exhibit 06_ConsigneeList_Professionals_17FEB2020 Exhibit 07_ConsigneeList_Patients_17RFEB2020
Questions about this recall
Why was it recalled?
hearing performance degradation due to body-fluid entering the device.
Which lots are affected?
Model Numbers: CI 1600 04 - HiRes Ultra with HF Mid-Scala Electrode CI 1600 05 - HiRes Ultra with HF Mid-Scala Electrode Lot Numbers - 1000000 thru 1999999.
Where was it sold?
Worldwide distribution - US Nationwide distribution and the countries of Canada, Brazil, Bangladesh, Switzerland, China, Australia, India, South Korea, Thailand, Ecuador, Mexico, El Salvador, Guatemala, Malaysia, Myanmar, Taiwan, Chile, Costa Rica, Colombia, Panama, Japan, Argentina, Peru, Singapore, China, New Zealand, Vietnam, Dominican Republic Refer to uploaded consignee lists in Associated Documents: Exhibit 05_ConsigneeList_Center_17FEB2020 Exhibit 06_ConsigneeList_Professionals_17FEB2020 Exhibit 07_ConsigneeList_Patients_17RFEB2020
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 85141| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | AB HiResolution Bionic Ear System, HiRes Ultra 3D CI recalled | Advanced Bionics | Potency & Assay | Nationwide |
More recalls from Advanced Bionics
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | HiResolution" Bionic Ear System HiRes Ultra 3D CI HiFocus Mid Scala recalled | Advanced Bionics | Device Malfunction | Nationwide |
| Device | CLASS II | HiResolution" Bionic Ear System M Zn-Air Battery Pak recalled | Advanced Bionics | Device Malfunction | Nationwide |
| Device | CLASS II | HiResolution Bionic Ear System Sky CI M90 Sound Processor recalled | Advanced Bionics | Packaging Defects | CA |
| Device | CLASS II | HiResolution" Bionic Ear System - M Battery Charger recalled | Advanced Bionics | Packaging Defects | 6 states |
| Device | CLASS III | AB PowerCel 230 (velvet black) recalled by Advanced Bionics | Advanced Bionics | Labeling Errors | Nationwide |
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