FDAFDA recall Z-3217-2026 · Sep 30, 2026
Midmark Corporation: Midmark IQvitals Zone recall
Recall found
Product
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 for recall
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Model No: 1-200-0320; UDI-DI: 00841709105791; Kit No: 4-000-0622; UDI-DI: 00841709105876; Kit Serial Number: V2900924; Zone Serial Number: V2899738
- Quantity
- 1 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- Midmark Corporation, Versailles, OH
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-21
Source: openFDA enforcement record Z-3217-2026 · search recall number Z-3217-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.