CLASS II ONGOING Device recall · Reported 2 Sep 2026 · FDA Enforcement Report

Digital ECG HD+12, HD+15 recalled by Midmark

Midmark is recalling Digital ECG HD+12, HD+15, distributed nationwide in the US. The recall was initiated on 20 Jul 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: This correction affects IQecg plugin software versions starting with v10 and prior to v10.1.0.18 installed on Midmark Digital ECG. The Midmark Digital ECG system information is provided below. The total quantities manufactured and distributed noted below are the combined IQecgs Digital ECG and Midmark Digital ECG systems. Serial Numbers: 7817519 7817645, L1130587 V2967564 UDI-DI: 00841709121319, 08056732652491

Quantity recalled3624 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-3013-2026
FDA event ID: 99404
Recalling firm: Midmark, Versailles, OH
Classification: Class II
Status: Ongoing
Recall initiated: 20 Jul 2026
FDA classified: 25 Aug 2026
Reported: 2 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Patient Monitors

Timeline

20 Jul 2026	Recall initiated by company
25 Aug 2026	Classified by FDA	+36 days
2 Sep 2026	Published in enforcement report	+8 days

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

Reason for recall

A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.

Product as listed by the FDA

Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.

Where it was distributed

Worldwide distribution - US Nationwide and the country of Canada.

Nationwide

Questions about this recall

Why was it recalled?

A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.

Which lots are affected?

Lot Code: This correction affects IQecg plugin software versions starting with v10 and prior to v10.1.0.18 installed on Midmark Digital ECG. The Midmark Digital ECG system information is provided below. The total quantities manufactured and distributed noted below are the combined IQecgs Digital ECG and Midmark Digital ECG systems. Serial Numbers: 7817519 7817645, L1130587 V2967564 UDI-DI: 00841709121319, 08056732652491

Where was it sold?

Worldwide distribution - US Nationwide and the country of Canada.

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 26 Sep 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

1 other product · FDA event 99404

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026	CLASS II	IQecg Digital ECG 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
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

Other Patient Monitors recalls

All 1,014

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	nGenuity Patient Monitor with Capnography recalled	Criticare Technologies	Device Malfunction	Nationwide
16 Sep 2026Device	CLASS I	Bravo CF capsule delivery device, Product Number FGS recalled	Given Imaging	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide