Facility

Cochlear Limited - Brisbane

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

Key facts

3recalls · worst Class II

—inspections in our data

—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)	3003045432
Establishment type	Manufacture Medical Device
Location	12 Helen Street Newstead Queensland, AU 4006
Registration status	Active · expires 2026
Parent company	COCHLEAR AMERICAS (owner-operator 9076254)
Brand names	NUCLEUS 24 COCHLEAR IMPLANT SYSTEM; Cochlear Nucleus Nexa cochlear implants; Cochlear surgical processors and accessories; Nucleus SmartNav; Cochlear Objective Measures; Custom Sound Pro; Nucleus Smart App; Cochlear Nucleus Kanso 3 Nexa Sound Processor and accessories; Cochlear Nucleus Kanso 3 Sound Processor and accessories; Cochlear Nucleus 8 Nexa Sound Processor and Accessories; Cochlear Surgical Instrument Upgrade Kit

Activity by year

Recalls (3)

Devices registered here (2)

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

Recalls & enforcement

Class IITerminated2018-12-18
Product was packaged with the Incorrect tamper proof battery door.
Class IITerminated2015-06-05
Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.
Class IITerminated2014-04-09
Cochlear America is recalling Cochlear Baha Soft Tissue Gauge due to possible manufacturing imperfection in the smooth surface of the metal that could potentially leave residual metal on the patient's skin.

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. “Cochlear Limited - Brisbane (FEI 3003045432) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003045432-cochlear-limited-brisbane/

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