RegWardenFDA facility compliance records
Facility

COCHLEAR LTD.

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

Activity by year

FDA actions on record by year2014: 1 recalls; 2015: 1 recalls; 2018: 1 recalls1’141’15’16’171’18’19’20’21’22’23’24’25’26
  • Recalls (3)

Devices registered here (1)

  • Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring
    Product code SEM (opens in a new tab) · Class II · Neurology · 21 CFR 882.1360

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.

Related

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 LTD. (FEI 3002806740) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002806740-cochlear-ltd/

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