RegWardenFDA facility compliance records
Company

EDAN Diagnostics, Inc.

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

Recalls by year

FDA actions on record by year2016: 1 recalls; 2017: 1 recalls; 2025: 1 recalls12016120172018201920202021202220232024120252026
  • Recalls (3)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2025-10-24
    As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
  • Class IITerminated2017-11-17
    Firm became aware that it distributed 7 units in the U.S. that included a function that had not been cleared by U.S. FDA.
  • Class IITerminated2016-06-23
    Incorrect CO2 readings with some patient monitors.

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. “EDAN Diagnostics, Inc. — 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-10043671-edan-diagnostics-inc/

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