FDA-Device2026-09-30Class IIPROCESSING DEFECT
Midmark IQvitals Zone vital signs monitor recalled for inaccurate blood pressure readings
What this means
Midmark's IQvitals Zone vital signs monitor may provide inaccurate blood pressure readings when using the Linear Deflation Method. The issue affects a limited number of units (33 total) distributed nationwide. No injuries have been reported.
- Check if your device matches Model 1-200-0360 with Kit 4-000-0724 and one of the affected serial numbers listed in the recall notice.
- Contact Midmark Corporation or your device supplier for instructions on correction or replacement.
- Do not rely solely on blood pressure readings from this device until the issue is resolved.
The agency's original wording
Hazard
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Intended for
All ages (0 months and older)
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
33 units
Manufactured in
60 Vista Dr, Versailles, OH, United States
Products
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: 1-200-0360 with Kit Number: 4-000-0724
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3220-2026More Midmark recalls
- FDA-Device2026-09-30Midmark IQvitals Zone blood pressure monitor recalled for inaccurate readings
- FDA-Device2026-09-30Midmark IQvitals Zone vital signs monitor recalled for inaccurate blood pressure readings
- FDA-Device2026-09-30Midmark IQvitals Zone vital signs monitor recalled for inaccurate blood pressure readings
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