AllClear
PricingSign in
FDAOctober 24, 2025device

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-invasive blood pressure...

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

06944413800618

Recall history

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

Own something like this?

AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.

Start free — 200 items, no card →
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-invasive blood pressure... — Recall Details · AllClear