Zio AT Clinical Reference Manual — Class II medical device recall Z-0183-2023
Ongoing recall by iRhythm Technologies, Inc., reported 2022-11-16, distributed in AL, AR, AZ, CA, CO, CT, DC, DE…. Ambulatory ECG monitoring system labeling update: 1) Clinically actionable arrhythmia notifications delayed un
| Recall number | Z-0183-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | iRhythm Technologies, Inc., Cypress, CA, United States |
| Recall initiated | 2022-09-28 |
| Classified | 2022-11-04 |
| Reported by FDA | 2022-11-16 |
| Distributed | AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV |
| Quantity | 1,443 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00869770000210 |
| Model numbers | ALB0031, ALB0034 |
Product
Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0183-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.