iRhythm Technologies, Inc. Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system
Brand
iRhythm Technologies, Inc.
Lot Codes / Batch Numbers
UDI-DI: 00869770000210, Model/Revision: ALB0031/07, ALB0034/03
Products Sold
UDI-DI: 00869770000210; Model/Revision: ALB0031/07, ALB0034/03
iRhythm Technologies, Inc. is recalling Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: AL due to Ambulatory ECG monitoring system labeling update: 1) Clinically actionable arrhythmia notifications delayed until patient registration is complete; 2). Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 9/28/2022, Field Safety Notice Labeling Corrections were sent to customers who were informed of labeling changes and that the firm intends to enhance the process of notifying patients that they are approaching the maximum limit for either symptomatic or asymptomatic transmissions by auto shipping another Zio AT patch to the patient. Customers are asked to do the following: 1) Please review this letter and disseminate it to the appropriate system providers and any personnel at your facility. Please share this notification with all device users within your facility to ensure they are aware of this notice. 2) Complete and return the customer reply form. Further questions can be directed to customer care at (888) 693-2401 or support@irhythmtech.com or your local sales representative.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, WA, WV, WI, DC
Page updated: Jan 10, 2026