Brand Name: HiResolution" Bionic Ear System Product recall
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…
Why was Brand Name: HiResolution" Bionic Ear System Product recalled?
Due to incorrect shelf-life expiration date.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- Advanced Bionics, LLC
- 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.
- Recall date
- June 10, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)