Brand Name: HiResolution" Bionic Ear System recallZ-2283-2026 · Advanced Bionics, LLC · initiated Apr 30, 2026

Why it was recalled

Due to incorrect shelf-life expiration date.

FDA root cause category: Under Investigation by firm

What the company 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.

Recall details

Recall number

Z-2283-2026

Status

Open, Classified

Initiated by the company

Apr 30, 2026

Posted by the FDA

Jun 1, 2026

Recalling firm

Advanced Bionics, LLC

Quantity

36

Product code

MCM

FDA submissions

P960058

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.

Product description

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• HiRes™ Ultra 3D CI HiFocus™ MS Electrode CI-1601-04

  Advanced Bionics, LLC · Implant, cochlear
  1 recall149 reports

Other devices under the same FDA submission

24 devices cleared under P960058 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• HiRes™ Ultra CI HiFocus™ MS Electrode CI-1600-04

  Advanced Bionics AG · Implant, Cochlear
  2,918 reports
• HiRes™ Ultra 3D CI HiFocus™ MS Electrode CI-1601-04

  Advanced Bionics AG · Implant, Cochlear
  1 death931 reports
• HiRes™ Ultra 3D CI HiFocus™ SlimJ Electrode CI-1601-05

  Advanced Bionics AG · Implant, Cochlear
  795 reports
• HiRes™ Ultra CI HiFocus™ SlimJ Electrode CI-1600-05

  Advanced Bionics AG · Implant, Cochlear
  335 reports
• HiRes 90K™ Advantage CI HiFocus™ MS Electrode CI-1500-04

  Advanced Bionics AG · Implant, Cochlear
  315 reports
• HiRes 90K™ Advantage CI HiFocus™ 1j Electrode CI-1500-01

  Advanced Bionics AG · Implant, Cochlear
  280 reports
• HiRes™ Ultra 3D CI HiFocus™ SlimJ Electrode CI-1601-05

  Advanced Bionics, LLC · Implant, cochlear
  1 death257 reports
• HiRes™ Ultra 3D CI HiFocus™ SlimJ Electrode CI-1601-05

  Advanced Bionics AG · Implant, Cochlear
  254 reports
• HiRes™ Ultra 3D CI HiFocus™ MS Electrode CI-1601-04

  Advanced Bionics AG · Implant, Cochlear
  195 reports
• HiRes™ Ultra CI HiFocus™ SlimJ Electrode CI-1600-05

  Advanced Bionics AG · Implant, Cochlear
  178 reports
• HiRes 90K™ Advantage CI HiFocus™ MS Electrode CI-1500-04

  Advanced Bionics AG · Implant, Cochlear
  1 recall127 reports
• HiRes 90K™ CI HiFocus™ 1j Electrode CI-1400-01

  Advanced Bionics AG · Implant, Cochlear
  54 reports