iRhythm Technologies, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0183-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system

Product Classification:

Class II

Date Initiated: September 28, 2022

Date Posted: November 16, 2022

Recall Number: Z-0183-2023

Event ID: 90954

Reason for Recall:

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 for either type, any further transmissions for that type will cease. Risk of delayed reporting to health providers.

Status: Ongoing

Product Quantity: 1,443

Code Information:

UDI-DI: 00869770000210; Model/Revision: ALB0031/07, ALB0034/03

Distribution Pattern:

US: MD, NY, FL, TN, WA, AL, MA, AZ, CA, KS, HI, PA, NJ, TX, MN, VA, AR, OR, NC, CO, KY, MS, LA, MI, WI, WV, IN, ID, SC, CT, SD, IA, NV, OK, OH, IL, VT, NH, NE, NM, MO, ME, DC, RI, MT, DE, GA, ND

Voluntary or Mandated:

Voluntary: Firm initiated