RegWardenFDA facility compliance records
Company

iRhythm Technologies, Inc.

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

Recalls by year

FDA actions on record by year2022: 1 recalls20172018201920202021120222023202420252026
  • Recalls (1)

Registered facilities (2)

Recalls & enforcement

  • Class IIOngoing2022-09-28
    Ambulatory ECG monitoring system labeling update: 1) Clinically actionable arrhythmia notifications delayed until patient registration is complete; 2) Patches limited to 100 symptomatic and 500 asymptomatic wireless transmissions; once the maximum transmission limit is reached fo…

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. “iRhythm Technologies, 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-10026250-irhythm-technologies-inc/

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