Midmark recall: IQecg Digital ECG and 1 more product
Midmark Corporation is recalling Midmark IQecg Digital ECG and 1 more product – 3624 units. The U.S. Food and Drug Administration published the recall on September 2, 2026; it began on July 20, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Midmark IQecg Digital ECG and 1 more product |
| Brand | Midmark |
| Company | Midmark Corporation |
| Type | Medical devices |
| Classification | Class II |
| Recall date | July 20, 2026 |
| Published by FDA | September 2, 2026 |
| Quantity | 3624 units |
| Recall ID | 99404 |
Recalled products (2)
- Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.
- FDA recall number
- Z-3012-2026
- Codes, lots and dates
- Lot Code: This correction affects IQecg plugin software versions starting with v10 and prior to v10.1.0.18 installed on Midmark IQecg Digital ECG. The Midmark IQecg 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: 480000 4820704 UDI-DI: 00841709100581, 00841709100321, 00841709100895, 00841709100901
- Quantity
- 3624 units
- Classification
- Class II
- 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.
- FDA recall number
- Z-3013-2026
- Codes, lots and dates
- 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
- Quantity
- 3624 units
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99404
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Versailles, OH, United States
Why it was recalled
The reason the FDA lists: “A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.”
Where it was sold
Nationwide. Distribution as the FDA records it: “Worldwide distribution - US Nationwide and the country of Canada.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99404, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other Midmark recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Sep 30, 2026 |  Midmark recall: IQvitals ZoneMedical devices · 1 units; 153 units; 20 units; 33 units | A performance issue may result in inaccurate blood pressure readings when the Linear Defla… Serious | FDA Class II |
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| Oct 7, 2026 | Draeger recall: VentStar Resus NeoMedical devices · 1,063,643 units | Potential cracks in the hose, which could lead to leakage or the hose falling off. Most serious | FDA Class I |
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| Oct 7, 2026 | Siemens Healthcare Diagnostics recall: Atellica CH Revised C-Reactive ProteinMedical devices · 42940 units (3938 US, 39002 OUS) | The potential for falsely elevated results. Serious | FDA Class II |
| Oct 7, 2026 | Tandem Diabetes Care recall: T:slim Mobile ApplicationMedical devices · 177 | A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a sof… Serious | FDA Class II |
About this recall
Is Midmark Midmark IQecg Digital ECG recalled?
Yes. Midmark Corporation recalled it on July 20, 2026; FDA published it September 2, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.