Facility

Advanced Bionics LLC

10 recall(s) on record — most severe on record: Class II.

Key facts

10recalls · worst Class II

2inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1000220815
Establishment type	Manufacture Medical Device
Location	28515 Westinghouse Pl Valencia, CA, US 91355
Registration status	Active · expires 2026
Parent company	Advanced Bionics LLC (owner-operator 10023794)
Brand names	CLARION CII BIONIC EAR; HIRESOLUTION BIONIC EAR SYSTEM; Sky CI M90 Sound Processor; Naida CI Q90; Naida CI Q70; Naida CI M90 Sound Processor; Naida CI M30 Sound Processor; Naida CI Q30

Activity by year

Recalls (10)
Inspections (2)

Devices registered here (1)

Implant, Cochlear
Product code MCM (opens in a new tab) · Class III · Unknown

Recalls & enforcement

Class IIOngoing2026-04-30
Due to incorrect shelf-life expiration date.
Class IIOngoing2026-03-23
The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell battery.
Class IIOngoing2025-11-27
Behind-the-ear sound processer packaging label is different then included product.
Class IIOngoing2025-03-05
Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
Class IIITerminated2020-09-26
Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
Class IITerminated2020-02-17
hearing performance degradation due to body-fluid entering the device.
Class IIITerminated2019-04-04
The manufacturer received complaints that customers were attempting to install the fitting software using the supplied USB drive, an error message was received, and installation failed. The failed installation has not impact to the current version of the software, and users are …
Class IIITerminated2019-03-18
Three materials used in the makeup of the implant were mistakenly left off the list of bio-compatible materials in the firm's previously approved submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan.
Class IITerminated2019-02-06
The sound processors were loaded with the incorrect firmware.
Class IITerminated2007-09-14
Advanced Bionics is recalling the the HiRes 90K cochlear implant with HiFocus Helix Electrode because of loose-fitting insertion tool assemblies.

FDA inspections (2)

NAI2019-05-08
No Action Indicated · Bioresearch Monitoring
NAI2018-09-28
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Advanced Bionics LLC (FEI 1000220815) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000220815-advanced-bionics-llc/

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