Advanced Bionics HiRes Ultra 3D CI HiFocus Mid Scala Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Advanced Bionics, LLC is recalling 36 units of the HiRes Ultra 3D CI HiFocus Mid Scala cochlear implant (model CI-1601-04) due to incorrect shelf-life expiration dates.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 10, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Advanced Bionics, LLC initiated a voluntary recall of the HiResolution Bionic Ear System component due to incorrect shelf-life expiration dates. The recall is classified as Class II by the FDA.
Which Products Are Affected
The affected product is the HiRes Ultra 3D CI HiFocus Mid Scala with model/catalog number CI-1601-04. A total of 36 units are involved, distributed nationwide in the United States to the states of CA, CO, GA, IL, IN, KS, MA, MD, MI, MO, MT, NC, TN, WA, and WI. Specific UDI codes and lot numbers are listed in the recall notice (recall number Z-2283-2026).
What You Should Do
Consumers and healthcare providers should refer to the recall notice for affected serial numbers and contact Advanced Bionics, LLC regarding the incorrect expiration dates.
Why This Matters
The recall affects cochlear implant devices intended for individuals with severe-to-profound hearing loss distributed across multiple U.S. states.
Source
FDA Recall Z-2283-2026 - Advanced Bionics, LLC, Valencia, CA
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,058 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to July 10, 2026.
Frequently Asked Questions
Common questions about this FDA recall.