FDAFDA · Food and drugs·Recall number Z-3217-2026
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
Published September 30, 2026 · Recall initiated: August 21, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Midmark Corporation
- Distributor
- US Nationwide distribution.
- Lot
- Model No: 1-200-0320; UDI-DI: 00841709105791; Kit No: 4-000-0622; UDI-DI: 00841709105876; Kit Serial Number: V2900924; Zone Serial Number: V2899738
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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Questions about this recall
Was 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 recalled?
Yes. FDA published recall Z-3217-2026 on September 30, 2026. Reported hazard: A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
What should I do if I have this product?
Voluntary: Firm initiated · Letter
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