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FDAOctober 24, 2025device

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of arterial blood oxygen saturation (SpO2), Pulse Rate and CO2 in a hospi...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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 device.

What to do

FDA enforcement status: Ongoing

Brands named

edan diagnosticsedan

UPCs

06944413800625

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of arterial blood oxygen saturation (SpO2), Pulse Rate and CO2 in a hospi... — Recall Details · AllClear