AB HiResolution Bionic Ear System — Class II medical device recall Z-2032-2020
Terminated recall by Advanced Bionics, LLC, reported 2020-05-27, distributed nationwide. hearing performance degradation due to body-fluid entering the device.
| Recall number | Z-2032-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Bionics, LLC, Valencia, CA, United States |
| Recall initiated | 2020-02-17 |
| Classified | 2020-05-15 |
| Reported by FDA | 2020-05-27 |
| Terminated | 2023-01-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BD, BR, CA, CH, CL, CN, CO, CR, DO, EC, GT, IN, JP, KR, MX, MY, NZ, PA, PE, SG, SV, TH, TW, VN |
| Reason classes | specification failure |
| Lot numbers | 1000000 |
| Model numbers | 1601 |
Product
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.
Reason for recall
hearing performance degradation due to body-fluid entering the device.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2032-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.