Advanced Bionics, Llc: Implant, Cochlear
Recall Summary Advanced Bionics is recalling HiRes Ultra 3D CI HiFocus Mid Scala cochlear implants nationwide because they were labeled with an incorrect expiration date. The cochlear implant system is surgically implanted to help people with severe hearing loss by converting sound into electrical signals that stimulate the auditory nerve. This is a Class III recall affecting implants distributed across the United States.
- 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...
- Reason
- Due to incorrect shelf-life expiration date.
- Classification
- Class III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-30
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/17e97a1b-70d2-4fc9-bb9c-77c95cf2bfed