Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: Recalled by Edan Diagnostics Due to As a result of receiving an FDA It...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Edan Diagnostics directly.
Affected Products
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 (NIBP), the oxygen saturation of the blood (SpO2) and Rectal/Oral/Auxiliary/Ear temperature measurement. Component: No
Quantity: 13934
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Edan Diagnostics
Edan Diagnostics has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report