Midmark IQvitals Zone recall (Midmark Corporation)
Medical deviceClass IIOngoing
Summary: Midmark Corporation is recalling 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.
What is being recalled
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
Why
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution.
How to tell if yours is affected
Model No: 1-200-0320; UDI-DI: 00841709105791; Kit No: 4-000-0622; UDI-DI: 00841709105876; Kit Serial Number: V2900924; Zone Serial Number: V2899738
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3217-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 21, 2026 |
| Reported | September 30, 2026 |
| Company | Midmark Corporation |
| Company location | Versailles, OH, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 1 units |
More recalls from Midmark Corporation · all medical device recalls · recalls from August 2026