RegWardenFDA facility compliance records
Company

eVent Medical

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

Recalls by year

FDA actions on record by year2015: 1 recalls1201520162017201820192020202120222023202420252026
  • Recalls (1)

Registered facilities (1)

Recalls & enforcement

  • Class ITerminated2015-10-13
    A component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming.

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. “eVent Medical — 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-9054964-event-medical/

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