RegWardenFDA facility compliance records
Company

ENVOY MEDICAL CORPORATION

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

Recalls by year

FDA actions on record by year2013: 1 recalls; 2018: 1 recalls1’13’14’15’16’171’18’19’20’21’22’23’24’25’26
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2018-06-28
    Sterile Wipes packed in these four Esteem II Sound Processors had an earlier expiration date than the final pack and the Esteem II Sound Processors. The Sterile Wipes expired prior to the date labeled on the final pack.
  • Class IITerminated2013-01-09
    Envoy Medical is conducting a voluntary correction of a limited number of Esteem Programmers, part of the Esteem Totally Implantable Hearing System, to reduce their susceptibility to noise interference.

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. “ENVOY MEDICAL CORPORATION — 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-9092560-envoy-medical-corporation/

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