Recall Z-3217-2026— Midmark Corporation
Class II · Ongoing
Class II FDA medical device recall by Midmark Corporation, initiated 2026-08-21. It names one FDA 510(k) clearance: K161909. Product: Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-0320 with Kit Number: 4-000-0622. Reason: A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used..
- Recalling firm
- Midmark Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-08-21
- Firm location
- Versailles, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-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 IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-0320 with Kit Number: 4-000-0622
Reason for recall
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Data sourced from openFDA. This site is unofficial and independent of the FDA.