RegWardenFDA facility compliance records
Facility

COCHLEAR BONE ANCHORED SOLUTIONS AB

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)

  • Hearing Aid, Bone Conduction, Implanted
    Product code MAH (opens in a new tab) · Class II · Ear, Nose, Throat · 21 CFR 874.3302

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 BONE ANCHORED SOLUTIONS AB (FEI 3003222064) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003222064-cochlear-bone-anchored-solutions-ab/

Not open yet

Alerts for COCHLEAR BONE ANCHORED SOLUTIONS AB

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.