COCHLEAR AMERICAS
3 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (3)
Registered facilities (7)
- Cochlear Malaysia Sdn Bhd FEI 3013177549 · MY
- COCHLEAR BONE ANCHORED SOLUTIONS AB FEI 3003222064 · SE
- COCHLEAR AMERICAS FEI 3005900820 · CO
- COCHLEAR LTD. FEI 3002806740 · AU
- Cochlear Limited - Brisbane FEI 3003045432 · AU
- Cochlear Americas Warehouse FEI 3014579188 · CO
- Cochlear Ltd FEI 3009092818 · AU
Recalls & enforcement
- Class IITerminated2018-12-18Product was packaged with the Incorrect tamper proof battery door.
- Class IITerminated2015-06-05Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.
- Class IITerminated2014-04-09Cochlear 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. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “COCHLEAR AMERICAS — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9076254-cochlear-americas/
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