Lower riskMedical device recall · FDA · Published February 17, 2020
Advanced Bionics Bionic Ear System Recall: Body Fluids Cause Hearing Degradation
Advanced Bionics recalls HiResolution Bionic Ear Systems (model CI 1600 04/05) due to hearing performance issues from body fluids entering the device. Affected units sold with lot numbers 1000000-1999999.
“Advanced Bionics Bionic Ear System Recall: Body Fluids Cause Hearing Degradation.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/65831-advanced-bionics-bionic-ear-system-recall-body-fluids-cause-hearing. Based on FDA recall #Z-2033-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2033-2020%22&limit=1).
Advanced Bionics, LLC recalled the AB HiResolution Bionic Ear System, HiRes Ultra CI, and MS Electrode due to hearing performance degradation from body-fluid entering the device, the FDA said on Feb. 17, 2020. Owners should contact the company for a remedy.
How to tell if you have it
Brand: Advanced Bionics
Product: AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode
Model Numbers: CI 1600 04, CI 1600 05
Lot Numbers: 1000000 thru 1999999
Units affected: 14068 (CI-1600-04 = 9772 units and CI-1600-05 = 4296 units)
Distribution: US Nationwide, 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, New Zealand, Vietnam, Dominican Republic
The hazard
The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve. The hazard is hearing performance degradation due to body-fluid entering the device.
Context
GovInfoNow's records show Advanced Bionics, LLC has 8 other recalls on record since Feb. 6, 2019. Other recent recalls of similar products include HiResolution Bionic Ear System Recall (April 30, 2026), HiResolution Bionic Ear System Battery Pak (March 23, 2026), and HiResolution Sky CI M90 Sound Processor Recall (Nov. 27, 2025). Medtronic Bio-Medicus Adult Cannula Kit Recall occurred on May 25, 2026.
How to tell if you have this one
Check for model numbers CI 1600 04 or CI 1600 05 on the device. The lot number should be between 1000000 and 1999999 if the product was sold in the United States.
Brand
Advanced Bion: Bionic Ear System
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
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
Recall number
Product, codes & lots
Quantity
Z-2032-2020
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.; Model Numbers: CI 1601 04 - HiRes Ultra 3D with HF Mid-Scala Electrode CI 1601 05 - HiRes Ultra 3D with HF SlimJ Electrode Lot Numbers - 1000000 thru 1999999.
8159 units (CI-1601-04 = 3827 units and CI-1601-05 = 4332 units)
Z-2033-2020
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.; 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.
14068 units (CI-1600-04 = 9772 units and CI-1600-05 = 4296 units)
Based on the official FDA remedy
What to do — step by step
Check Device Model
Identify the model number on the device, which should be CI 1600 04 or CI 1600 05.
Verify Lot Number
Confirm the lot number is between 1000000 and 1999999 to determine if the product is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.9 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2033-2020 (February 17, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2033-2020 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.