FDA Medical devices recall ·
Midmark IQvitals Zone, automatically and noninvasively measures systolic… recall
- Recall number
- Z-3217-2026
- Date
- (initiated August 21, 2026)
- Company / brand
- Midmark Corporation
60 Vista Dr, Versailles, OH, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No: 1-200-0320; UDI-DI: 00841709105791; Kit No: 4-000-0622; UDI-DI: 00841709105876; Kit Serial Number: V2900924; Zone Serial Number: V2899738
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3217-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.