FDA recall Z-3218-2026

Midmark Corporation · Class II · device

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: 1-200-03300 with Kit Number: 4-000-0624

Reason for recall

A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2026-08-21
Report date
2026-09-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Versailles, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3218-2026