{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "220176", "product_res_number": "Z-2283-2026", "event_date_initiated": "2026-04-30", "event_date_posted": "2026-06-01", "recall_status": "Open, Classified", "res_event_number": "98916", "product_code": "MCM", "pma_numbers": [ "P960058" ], "product_description": "Brand Name: HiResolution\" Bionic Ear System\nProduct Name: HiRes Ultra 3D CI HiFocus Mid Scala\nModel/Catalog Number: CI-1601-04\nSoftware Version: N/A\nProduct 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.\nComponent: N/A", "code_info": "Model Number: CI-1601-04\nUDI codes:\n(01)00840094455993(11)260220(17)290228(21)2225141\n(01)00840094455993(11)260220(17)290228(21)2225150\n(01)00840094455993(11)260220(17)290228(21)2225152\n(01)00840094455993(11)260220(17)290228(21)2225155\n(01)00840094455993(11)260220(17)290228(21)2225160\n(01)00840094455993(11)260220(17)290228(21)2225188\n(01)00840094455993(11)250929(17)280930(21)2227161\n(01)00840094455993(11)260309(17)290331(21)2229827\n(01)00840094455993(11)260309(17)290331(21)2229839\n(01)00840094455993(11)260309(17)290331(21)2229849\n(01)00840094455993(11)250918(17)280930(21)2214172\n(01)00840094455993(11)260220(17)290228(21)2225146\n(01)00840094455993(11)260220(17)290228(21)2225154\n(01)00840094455993(11)260220(17)290228(21)2225168\n(01)00840094455993(11)260220(17)290228(21)2225189\n(01)00840094455993(11)250929(17)280930(21)2226476\n(01)00840094455993(11)250929(17)280930(21)2227006\n(01)00840094455993(11)250929(17)280930(21)2227007\n(01)00840094455993(11)250929(17)280930(21)2227012\n(01)00840094455993(11)250929(17)280930(21)2227038\n(01)00840094455993(11)250929(17)280930(21)2227071\n(01)00840094455993(11)250929(17)280930(21)2227112\n(01)00840094455993(11)250929(17)280930(21)2227122\n(01)00840094455993(11)250929(17)280930(21)2227129\n(01)00840094455993(11)250929(17)280930(21)2227148\n(01)00840094455993(11)250929(17)280930(21)2227151\n(01)00840094455993(11)250929(17)280930(21)2227183\n(01)00840094455993(11)250929(17)280930(21)2227196\n(01)00840094455993(11)250929(17)280930(21)2227202\n(01)00840094455993(11)250929(17)280930(21)2227207\n(01)00840094455993(11)250929(17)280930(21)2227212\n(01)00840094455993(11)250929(17)280930(21)2227215\n(01)00840094455993(11)250929(17)280930(21)2227220\n(01)00840094455993(11)250929(17)280930(21)2227235\n(01)00840094455993(11)260309(17)290331(21)2229803\n(01)00840094455993(11)260309(17)290331(21)2229836\nLot Numbers:\n2225141\n2225150\n2225152\n2225155\n2225160\n2225188\n2227161\n2229827\n2229839\n2229849\n2214172\n2225146\n2225154\n2225168\n2225189\n2226476\n2227006\n2227007\n2227012\n2227038\n2227071\n2227112\n2227122\n2227129\n2227148\n2227151\n2227183\n2227196\n2227202\n2227207\n2227212\n2227215\n2227220\n2227235\n2229803\n2229836\n\n\nLot Code: Serial Number/UDI Refer to Exhibit_0005", "firm_fei_number": "1000220815", "recalling_firm": "Advanced Bionics, LLC", "address_1": "28515 Westinghouse Pl", "city": "Valencia", "state": "CA", "postal_code": "91355-1398", "additional_info_contact": "Michelle Caulfield\n+1-707-4810011", "reason_for_recall": "Due to incorrect shelf-life expiration date.", "root_cause_description": "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.\n\nCustomers are instructed to:\n\" Please review and correct internal patient records to ensure they accurately reflect\nthe products expiration date.\n\" Reply to this email with your selected responses to the effectiveness questionnaire\nincluded below.\n\nContact Advanced Bionics customer service at 1-877-829-0026 to return the\naffected device and for any questions regarding this Recall.", "product_quantity": "36", "distribution_pattern": "U.S. Nationwide distribution in the states of CA, CO, GA, IL, IN, KS, MA, MD, MI, MO, MT, NC, TN, WA and WI.", "openfda": { "pma_number": [ "P000015", "P960058", "P840024", "P970051", "P830069", "P000025", "P890027", "P200021", "P940022" ], "device_name": "Implant, Cochlear", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2030624", "3002808022", "3007743836", "3005210579", "3009092818", "3033788852", "3012654499", "3030784382", "3002806740", "9710014", "8043792", "3010363503", "3034170504", "1721676", "9611813", "3020283264", "3014579188", "3005900820", "3009762645", "3008947133", "3011823740", "3013177549", "9613646" ], "fei_number": [ "3003045432", "3002806685", "3002808022", "3000206435", "3007743836", "3005210579", "3009092818", "1000220815", "3033788852", "3012654499", "3030784382", "3002806740", "3000249315", "3010363503", "3034170504", "3002808269", "1721676", "3020283264", "3014579188", "3005900820", "3008947133", "3011823740", "3013177549" ] } } ] }