Skip to main content
AREAZINENotices · US CA UK AU

FDAJuly 20, 2026

Midmark Digital ECG Recall Issued for Software Anomaly

FDA published this notice on July 20, 2026 for United States and Canada.

This notice is kept at its address for anyone who saved the link. AreaZine no longer holds the agency's full record for it, so the page shows what AreaZine recorded and links to the agency's own page, the one to read.

What AreaZine recorded

Agency
FDA
Place
United States and Canada
Date
July 20, 2026
Recall class
Class II
Reason given by the agency
A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Official source
the notice at its source

Official warnings by state, with every type counted since 2008Search notices, places and declaration numbers

Source: FDA.

The record around this notice