Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra… — Class II medical device recall Z-2283-2026
Ongoing recall by Advanced Bionics, LLC, reported 2026-06-10, distributed nationwide. Due to incorrect shelf-life expiration date.
| Recall number | Z-2283-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Bionics, LLC, Valencia, CA, United States |
| Recall initiated | 2026-04-30 |
| Classified | 2026-06-01 |
| Reported by FDA | 2026-06-10 |
| Distributed | Nationwide (US) |
| Quantity | 36 |
| UPC / GTIN / UDI-DI | 00840094455993 |
| Lot numbers | 2214172, 2225141, 2225146, 2225150, 2225152, 2225154, 2225155, 2225160, 2225168, 2225188, 2225189, 2226476, 2227006, 2227007, 2227012, 2227038, 2227071, 2227112, 2227122, 2227129, 2227148, 2227151, 2227161, 2227183, 2227196, 2227202, 2227207, 2227212, 2227215, 2227220, 2227235, 2229803, 2229827, 2229836, 2229839, 2229849 |
| Model numbers | CI-1601-04 |
Product
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) electrode array that are implanted surgically under the skin behind the ear. The external components include a sound processor (body-worn or ear-level), a headpiece, and a cable. The system converts sound into electrical energy that activates the auditory nerve. The auditory nerve then sends information to the brain, where it is interpreted as sound. Component: N/A
Reason for recall
Due to incorrect shelf-life expiration date.
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-2283-2026. 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.