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HiRes Ultra 3D CI HiFocus Mid Scala Cochlear Implant
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MEDICAL DEVICE RECALLMODERATE

HiRes Ultra 3D CI HiFocus Mid Scala Cochlear Implant

Advanced Bionics is recalling the HiRes Ultra 3D CI HiFocus Mid Scala cochlear implant due to an incorrect shelf-life expiration date.

What to do

Contact your healthcare provider or Advanced Bionics to verify the shelf-life status of your device and determine if replacement is necessary.

Recalled
Listed
Updated
Recall No.
Z-2283-2026
Agency
FDA
Firm
Advanced Bionics, LLC
Recall ID
98916
Status
ONGOING

Why it was recalled

Advanced Bionics is recalling the HiRes Ultra 3D CI HiFocus Mid Scala cochlear implant due to an incorrect shelf-life expiration date listed on the product packaging. This recall affects the internal receiver and electrode array components.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

HiResolution" Bionic Ear System HiRes Ultra 3D CI HiFocus Mid ScalaModel/Catalog number: CI-1601-04

Lot codeUDI-DI
–00840094455993, 00840094455993, 00840094455993, 00840094455993, 00840094455993, 00840094455993, 00840094455993, 00840094455993, 00840094455993, 00840094455993, 00840094455993, 00840094455993, 00840094455993, 00840094455993, 00840094455993, 00840094455993, 00840094455993, 00840094455993, 00840094455993, 00840094455993
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, 222983600840094455993, 260220, 290228, 2225141, 2225150, 2225152, 2225155, 2225160, 2225188, 250929, 280930, 2227161, 260309, 290331, 2229827, 2229839, 2229849, 250918, 2214172, 2225146, 2225154, 2225168, 2225189, 2226476, 2227006, 2227007, 2227012, 2227038, 2227071, 2227112, 2227122, 2227129, 2227148, 2227151, 2227183, 2227196, 2227202, 2227207, 2227212, 2227215 (+4 more, see the official notice)

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification