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RecallWatchMedical Device Safety
Class IIOngoingZ-2283-2026

Advanced Bionics, LLC recalls Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mi…

Advanced Bionics, LLCValencia, CA, United StatesReported Jun 10, 2026 · 2 months ago
Legal News Analyst ·

Reason for recall

Due to incorrect shelf-life expiration date.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    UDI codesModel Number
    36 affected lots
    22251412225150222515222251552225160222518822271612229827
    +28 more2229839222984922141722225146222515422251682225189222647622270062227007222701222270382227071222711222271222227129222714822271512227183222719622272022227207222721222272152227220222723522298032229836

What the firm is doing

On 04/30/2026, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that HiRes" Ultra 3D HiFocus MS CI (CI-1601-04) were labeled with an expiration date that exceeded the approved 3 year shelf life for the device. Customers are instructed to: " Please review and correct internal patient records to ensure they accurately reflect the products expiration date. " Reply to this email with your selected responses to the effectiveness questionnaire included below. Contact Advanced Bionics customer service at 1-877-829-0026 to return the affected device and for any questions regarding this Recall.

DistributionShow details

U.S. Nationwide distribution in the states of CA, CO, GA, IL, IN, KS, MA, MD, MI, MO, MT, NC, TN, WA and WI.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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