FDA Medical Device Recalls (openFDA)
Advanced Bionics, LLC: 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
- Recall number
- Z-2283-2026
- Recalling firm
- Advanced Bionics, LLC
- 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
- Status
- Open, Classified
- Initiated
- 2026-04-30
- Posted
- 2026-06-01
- Terminated
- not on file
- Reason
- Due to incorrect shelf-life expiration date.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 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.
- Lot, serial or model codes
- Model Number: CI-1601-04 UDI codes: (01)00840094455993(11)260220(17)290228(21)2225141 (01)00840094455993(11)260220(17)290228(21)2225150 (01)00840094455993(11)260220(17)290228(21)2225152 (01)00840094455993(11)260220(17)290228(21)2225155 (01)00840094455993(11)260220(17)290228(21)2225160 (01)00840094455993(11)260220(17)290228(21)2225188 (01)00840094455993(11)250929(17)280930(21)2227161 (01)00840094455993(11)260309(17)290331(21)2229827 (01)00840094455993(11)260309(17)290331(21)2229839 (01)00840094455993(11)260309(17)290331(21)2229849 (01)00840094455993(11)250918(17)280930(21)2214172 (01)00840094455993(11)260220(17)290228(21)2225146 (01)00840094455993(11)260220(17)290228(21)2225154 (01)00840094455993(11)260220(17)290228(21)2225168 (01)00840094455993(11)260220(17)290228(21)2225189 (01)00840094455993(11)250929(17)280930(21)2226476 (01)00840094455993(11)250929(17)280930(21)2227006 (01)00840094455993(11)250929(17)280930(21)2227007 (01)00840094455993(11)250929(17)280930(21)2227012 (01)00840094455993(11)250929(17)280930(21)2227038 (01)00840094455993(11)250929(17)280930(21)2227071 (01)00840094455993(11)250929(17)280930(21)2227112 (01)00840094455993(11)250929(17)280930(21)2227122 (01)00840094455993(11)250929(17)280930(21)2227129 (01)00840094455993(11)250929(17)280930(21)2227148 (01)00840094455993(11)250929(17)280930(21)2227151 (01)00840094455993(11)250929(17)280930(21)2227183 (01)00840094455993(11)250929(17)280930(21)2227196 (01)00840094455993(11)250929(17)280930(21)2227202 (01)00840094455993(11)250929(17)280930(21)2227207 (01)00840094455993(11)250929(17)280930(21)2227212 (01)00840094455993(11)250929(17)280930(21)2227215 (01)00840094455993(11)250929(17)280930(21)2227220 (01)00840094455993(11)250929(17)280930(21)2227235 (01)00840094455993(11)260309(17)290331(21)2229803 (01)00840094455993(11)260309(17)290331(21)2229836 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 Lot Code: Serial Number/UDI Refer to Exhibit_0005
- 510(k) numbers
- not on file
- PMA numbers
- P960058
- Product code
- MCM
- Firm FEI
- 1000220815
- Firm city
- Valencia
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06