Midmark IQecg Digital ECG — Class II medical device recall Z-3012-2026
Ongoing recall by Midmark Corporation, reported 2026-09-02, distributed nationwide. A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate bea
| Recall number | Z-3012-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Midmark Corporation, Versailles, OH, United States |
| Recall initiated | 2026-07-20 |
| Classified | 2026-08-25 |
| Reported by FDA | 2026-09-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 3,624 units |
| UPC / GTIN / UDI-DI | 00841709100321, 00841709100581, 00841709100895, 00841709100901 |
| Serial numbers | 480000, 4820704 |
| Model numbers | 4-000-0061, 4-000-0062 |
Product
Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.
Reason for recall
A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
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-3012-2026. 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.