FDA-Device2026-01-28Class IIPROCESSING DEFECT
Edan M3A Vital Signs Monitor recalled for cybersecurity vulnerabilities
What this means
The FDA identified potential cybersecurity issues with certain Edan M3A Vital Signs Monitors used in healthcare settings. These portable devices measure blood pressure, oxygen levels, and temperature. The FDA sent a letter to the manufacturer asking them to address the security vulnerabilities.
- Check if your device serial number matches the recall list
- Contact your device supplier or Edan Diagnostics for guidance on a fix or replacement
- Do not discard the device; await manufacturer instructions
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.
Affected count
12201
Manufactured in
9833 Pacific Heights Blvd, San Diego, CA, United States
Products
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A 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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1153-2026Want us to check the next one for you?
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