Facility

iRhythm Technologies, Inc.

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

Key facts

1recalls · worst Class II

2inspections · worst OAI

1warning letters

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3021769057
Establishment type	Manufacture Medical Device
Location	6550 Katella Avenue Cypress, CA, US 90630
Registration status	Active · expires 2026
Parent company	iRhythm Technologies, Inc. (owner-operator 10026250)
Brand names	Zio® AT Patch; Zio® AT Gateway; ZEUS System

Activity by year

Recalls (1)
Inspections (2)
Warning letters (1)

Devices registered here (5)

Transmitters And Receivers, Electrocardiograph, Telephone
Product code DXH (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2920
Outpatient Cardiac Telemetry
Product code QYX (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1025
Recorder, Magnetic Tape, Medical
Product code DSH (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2800
Computer, Diagnostic, Programmable
Product code DQK (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1425
Detector And Alarm, Arrhythmia
Product code DSI (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1025

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…

FDA inspections (2)

OAI2022-08-12
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2018-10-30
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Warning Letter2023-05-25
Warning Letter (opens in a new tab) · Cypress California

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “iRhythm Technologies, Inc. (FEI 3021769057) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3021769057-irhythm-technologies-inc/

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