Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
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
Why it was recalled
Due to incorrect shelf-life expiration date.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
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
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
U.S. Nationwide distribution in the states of CA, CO, GA, IL, IN, KS, MA, MD, MI, MO, MT, NC, TN, WA and WI.
Recall record
- Recalling firm
- Advanced Bionics, LLC
- Product type
- Devices
- Recall number
- Z-2283-2026
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Valencia, CA
- Recall initiated
- 2026-04-30
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-2283-2026 · Source: openFDA enforcement.