Recall Z-3013-2026— Midmark Corporation

Name: FDA recall Z-3013-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-20

Class II · Ongoing

Class II FDA medical device recall by Midmark Corporation, initiated 2026-07-20. It names one FDA 510(k) clearance: K220526. Product: Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.. Reason: A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation..

Recalling firm: Midmark Corporation
Classification: Class II
Status: Ongoing
Initiated: 2026-07-20
Firm location: Versailles, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K220526 — HD+12, HD+15Cardioline S.P.A·cleared 2023-05-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.