Lower risk Medical device recall · FDA · Published April 30, 2026

HiResolution Bionic Ear System Recall: Incorrect Shelf-Life Expiration Date

HiResolution recalls HiRes Ultra 3D CI HiFocus Mid Scala cochlear implants due to incorrect shelf-life expiration dates. Affected units may expire prematurely, leading to potential product failure.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2283-2026Medical device HiResolution ›

Lower-risk recall

Due to incorrect shelf-life expiration date.

Take action

Contact the company

Recalling firmAdvanced Bionics, LLC28515 Westinghouse Pl · Valencia, CA 91355-1398

✎ GovInfoNow plain-language explainer

HiResolution is recalling its HiRes Ultra 3D CI HiFocus Mid Scala cochlear implants because they have incorrect shelf-life expiration dates. This could cause the implants to expire prematurely, potentially leading to product failure. Read more at govinfonow.com/recall/49289-hiresolution-bionic-ear-system-recall-incorrect-shelf-life-expiration-date.

Source Summary by GovInfoNow · govinfonow.com/recall/49289-hiresolution-bionic-ear-system-recall-incorrect-shelf-life-expiration-date · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2283-2026

Cite this page

“HiResolution Bionic Ear System Recall: Incorrect Shelf-Life Expiration Date.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49289-hiresolution-bionic-ear-system-recall-incorrect-shelf-life-expiration-date. Based on FDA recall #Z-2283-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2283-2026%22&limit=1).

The FDA announced on April 30, 2026, that Advanced Bionics, LLC voluntarily recalled the HiResolution Bionic Ear System due to an incorrect shelf-life expiration date. The agency issued recall number Z-2283-2026 for the Class II device.

How to tell if you have it

Brand: HiResolution
Product Name: HiRes Ultra 3D CI HiFocus Mid Scala
Model/Catalog Number: CI-1601-04
UPC: 00840094455993
Lot Numbers: 2225141, 2225150, 2225152, 2225155, 2225160, 2225188, 2227161, 2229827, 2229839, 2229849, 2214172, 2225146, 2225154, 2225168, 2225189, 2226476, 2227006, 2227007, 2227012, 2227038, 2227071, 2227112, 2227122, 2227129, 2227148, 2227151, 2227183, 2227196, 2227202, 2227207, 2227212, 2227215, 2227220, 2227235, 2229803, 2229836
Units affected: 36

The hazard

The recall is due to an incorrect shelf-life expiration date on the HiResolution Bionic Ear System. The product description states the system consists of internal components including the HiRes Ultra 3D receiver and HiFocus Mid-Scala electrode array, along with external sound processor components.

Context

GovInfoNow's records show Advanced Bionics, LLC has 8 other recalls on record since February 6, 2019. Recent similar recalls include the HiResolution Sky CI M90 Sound Processor Recall dated November 27, 2025, and the HiResolution Bionic Ear System M Battery Charger Recall dated March 5, 2025. Other recent recalls of similar products include the Inspire Stimulation Lead Recall (May 11, 2026), the Miach BEAR Implant Model 1000 recall (December 31, 2025), and the Cook Medical Spectrum Central Venous Tray Recall (March 5, 2026).

How to tell if you have this one

Check for the model number CI-1601-04 on the implant. Affected units include specific lot numbers listed in the recall notice, such as 2225141, 2225150, and others.

Brand
HiResolution
Product
Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Model
Look for the model number CI-1601-04 on the implant to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 15 states.

FDA distribution: “U.S. Nationwide distribution in the states of CA, CO, GA, IL, IN, KS, MA, MD, MI, MO, MT, NC, TN, WA and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Colorado, Georgia, Illinois, Indiana, Kansas, Maryland, Massachusetts, Michigan, Missouri, Montana, North Carolina, Tennessee, Washington, Wisconsin.

Recall timeline

FDA published this recall 41 days after the firm started it.

Apr 30, 2026Firm started the recall
Jun 1, 2026FDA classified it Class II
Jun 10, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other HiResolution recalls

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Keep exploring

More HiResolution recalls

Link to this recall

<a href="https://govinfonow.com/recall/49289-hiresolution-bionic-ear-system-recall-incorrect-shelf-life-expiration-date">HiResolution Bionic Ear System Recall: Incorrect Shelf-Life Expiration Date (GovInfoNow)</a>

Where this comes from

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-2283-2026 (April 30, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2283-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.