CLASS II ONGOING Device recall · Reported 30 Sep 2026 · FDA Enforcement Report

IQvitals Zone, automatically recalled by Midmark

Midmark is recalling IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood, distributed nationwide in the US. The recall was initiated on 21 Aug 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel No: 1-200-0350; UDI-DI: 00841709105821; Kit No: 4-000-0722; UDI-DI: 00841709105906; Kit Serial Number: V2866143 V2866111 V2866124 V2864892 V2864113 V2864444 V2864120 V2864449 V2864894 V2866626 V2866636 V2871280 V2870561 V2869170 V2870570 V2869930 V2874364 V2897744 V2900961 V2900947; Zone Serial Number: V2864929 V2865546 V2864921 V2864495 V2796056 V2864174 V2858651 V2864142 V2873819 V2866216 V2866187 V2870249 V2870090 V2867500 V2866707 V2869394 V2873111 V2886635 V2873150 V2886126

Quantity recalled20 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3219-2026
FDA event ID: 99641
Recalling firm: Midmark, Versailles, OH
Classification: Class II
Status: Ongoing
Recall initiated: 21 Aug 2026
FDA classified: 18 Sep 2026
Reported: 30 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

21 Aug 2026	Recall initiated by company
18 Sep 2026	Classified by FDA	+28 days
30 Sep 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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: 1-200-0350 with Kit Number: 4-000-0722

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Model No: 1-200-0350; UDI-DI: 00841709105821; Kit No: 4-000-0722; UDI-DI: 00841709105906; Kit Serial Number: V2866143 V2866111 V2866124 V2864892 V2864113 V2864444 V2864120 V2864449 V2864894 V2866626 V2866636 V2871280 V2870561 V2869170 V2870570 V2869930 V2874364 V2897744 V2900961 V2900947; Zone Serial Number: V2864929 V2865546 V2864921 V2864495 V2796056 V2864174 V2858651 V2864142 V2873819 V2866216 V2866187 V2870249 V2870090 V2867500 V2866707 V2869394 V2873111 V2886635 V2873150 V2886126

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 6 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 99641

This product is part of a recall event; the main page for the event is IQvitals Zone, automatically recalled by Midmark.

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026	CLASS II	IQvitals Zone, automatically recalled by Midmark	Midmark	Labeling Errors	Nationwide
30 Sep 2026	CLASS II	IQvitals Zone, automatically recalled by Midmark	Midmark	Labeling Errors	Nationwide
30 Sep 2026	CLASS II	IQvitals Zone, automatically recalled by Midmark	Midmark	Labeling Errors	Nationwide

More recalls from Midmark

All 8

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	IQvitals Zone, automatically recalled by Midmark	Midmark	Labeling Errors	Nationwide
30 Sep 2026Device	CLASS II	IQvitals Zone, automatically recalled by Midmark	Midmark	Labeling Errors	Nationwide
30 Sep 2026Device	CLASS II	IQvitals Zone, automatically recalled by Midmark	Midmark	Labeling Errors	Nationwide
2 Sep 2026Device	CLASS II	IQecg Digital ECG recalled by Midmark	Midmark	Labeling Errors	Nationwide
2 Sep 2026Device	CLASS II	Digital ECG HD+12, HD+15 recalled by Midmark	Midmark	Labeling Errors	Nationwide

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