FDA-Device2026-09-30Class IIPROCESSING DEFECT
Midmark IQvitals Zone vital signs monitor recalled for inaccurate blood pressure readings
What this means
Midmark Corporation's IQvitals Zone vital signs monitor may produce inaccurate blood pressure readings when using the Linear Deflation Method. The device measures blood pressure, pulse, temperature, and oxygen levels for adult and pediatric patients. A limited number of units with specific serial numbers are affected.
- Check if your device's model and serial numbers match the FDA recall list.
- Contact Midmark Corporation for instructions on how to proceed.
- Do not rely on blood pressure readings from affected units until you receive further guidance.
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
153 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: 1-200-03300 with Kit Number: 4-000-0624
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3218-2026More Midmark recalls
- FDA-Device2026-09-30Midmark IQvitals Zone vital signs monitor recalled for inaccurate blood pressure readings
- 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
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