Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1

FDA device recall Z-2283-2026 · posted 2026-06-01 · Open, Classified

Recall details

Recalling firm

Advanced Bionics, LLC

Reason for recall

Due to incorrect shelf-life expiration date.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

MCM

Quantity affected

36

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.

Date initiated

2026-04-30

Date posted

2026-06-01

Location

Valencia, CA