RegWardenFDA facility compliance records
Company

Dignitana Inc

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

Recalls by year

FDA actions on record by year2021: 1 recalls20172018201920201202120222023202420252026
  • Recalls (1)

Registered facilities (2)

Recalls & enforcement

  • Class IITerminated2021-11-05
    Instructions for Use (IFUs) updated to include use of a headband is now recommended for all patients and instructions for the application of the headband. Additionally, IFU updated to include warnings for risk of condensation build up depending on environmental conditions with in…

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. “Dignitana 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-10050834-dignitana-inc/

Not open yet

Alerts for Dignitana Inc

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.