Quick Facts at a Glance
- Recall Date
- April 30, 2026
- Hazard Level
- HIGH
- Brand
- Advanced Bionics
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Advanced Bionics
- Model numbers
- 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
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
April 30, 2026
Reported by FDA DEVICE
June 10, 2026
RecallRadar source check
June 16, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Due to incorrect shelf-life expiration date.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Advanced Bionics, LLC or your healthcare provider for instructions. Notification method: Letter
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Full 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. Reason: Due to incorrect shelf-life expiration date.. Classification: Class II. 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.
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