Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, tempe
Summary
The FDA issued a Class II for Midmark IQvitals Zone, automatically and noninvasively measures systolic and dia by Midmark Corporation. Reason: A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used..
Details
Source
Device Recall
External ID
Z-3217-2026
Action Date
2026-09-30
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: 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 Affected: 1 units
Reason for Recall
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-21
Company
Versailles, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 196 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Midmark Corporation has 9 FDA actions in our database, including 6 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Midmark Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Midmark Corporation have FDA actions?
Midmark Corporation has 9 FDA actions in our database, including 6 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3217-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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