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-3220-2026
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: 1-200-0360 with Kit Number: 4-000-0724
Lot/Code Info: Model No: 1-200-0360; UDI-DI: 00841709105838; Kit No: 4-000-0724; UDI-DI: 00841709105913; Kit Serial Number: V2788703 V2788046 V2788016 V2788712 V2789302 V2789846 V2789830 V2789837 V2789808 V2789303 V2789304 V2811103 V2811112 V2862288 V2862275 V2869139 V2866577 V2867451 V2869599 V2868801 V2869154 V2868545 V2866984 V2869980 V2869969 V2868130 V2867433 V2868182 V2924525 V2924566 V2924559 V2924539 V2927525; Zone Serial Number: V2788322 V2787552 V2787555 V2788321 V2788905 V2789498 V2787554 V2789488 V2789499 V2788922 V2787553 V2807891 V2807893 V2837260 V2859050 V2868888 V2862992 V2866942 V2868893 V2868239 V2868840 V2868222 V2866940 V2868892 V2869397 V2867491 V2866963 V2868051 V2923639 V2922999 V2922998 V2923640 V2927201
Quantity Affected: 33 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-3220-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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