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: 1-200-0360; 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 recalled33 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-3220-2026
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: 1-200-0360 with Kit Number: 4-000-0724

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: 1-200-0360; 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

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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