Recall archive
3 recalls · page 1 of 1
Reported Jan 28, 2026
Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Edan Diagnostics
Matched: Brand · Product · Product details — As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm…
15 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 26, 2020
EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Edan Diagnostics
Matched: Brand · Product · Product details — Firm became aware that it distributed 7 units in the U.S. that included a function that had not been cleared by U.S. FDA.
FDA (openFDA device enforcement)
Reported Aug 17, 2016
EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Edan Diagnostics
Matched: Brand — Incorrect CO2 readings with some patient monitors.
FDA (openFDA device enforcement)
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