Midmark IQvitals Zone
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Midmark Corporation of Versailles, Ohio, recalled IQvitals Zone because a performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. The recall began August 21, 2026, and was added to the FDA's Enforcement Report on September 18, 2026.
The IQvitals Zone, which automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, was distributed nationwide.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
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
- 1-200-0320
- 1-200-03300
- 1-200-0350
- 1-200-0360
Product details
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: 1-200-0350 with Kit Number: 4-000-0722
- UDI-DI
- 00841709105821
- 00841709105906
Product details
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
- UDI-DI
- 00841709105807
- 00841709105883
Product details
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
- UDI-DI
- 00841709105791
- 00841709105876
Product details
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
- UDI-DI
- 00841709105838
- 00841709105913
Details
- Company began the recall
- Sold in
US Nationwide distribution.
- Event ID
- 99641
- Recall numbers
- Z-3217-2026 to Z-3220-2026
- Company
- Midmark CorporationVersailles, Ohio
- Hazard
- Device defect
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Letter
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
