FDA Medical Device · Z-3217-2026

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

Class II · Ongoing

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

Affected lots / codes — check yours against thisModel No: 1-200-0320; UDI-DI: 00841709105791; Kit No: 4-000-0622; UDI-DI: 00841709105876; Kit Serial Number: V2900924; Zone Serial Number: V2899738

Recalling firm: Midmark Corporation, Versailles, OH
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 1 units
Distribution: US Nationwide distribution.
Recall initiated: August 21, 2026
Classified: September 18, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3217-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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