FDA-Device2026-09-30Class IIPROCESSING DEFECT
Midmark IQvitals Zone blood pressure monitor recalled for inaccurate readings
What this means
Midmark Corporation's IQvitals Zone vital signs monitor may display inaccurate blood pressure readings when using the Linear Deflation Method. This affects Model 1-200-0320 with Kit 4-000-0622. The device measures blood pressure, pulse, temperature, and oxygen saturation for adult and pediatric patients.
- Stop using the Linear Deflation Method on affected units.
- Contact Midmark Corporation for instructions on how to proceed with your device.
- Check your device's model and kit numbers against the recall details.
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
1 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: 1-200-0320 with Kit Number: 4-000-0622
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3217-2026More Midmark recalls
- 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
- FDA-Device2026-09-30Midmark IQvitals Zone vital signs monitor recalled for inaccurate blood pressure readings
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