FDA-Device2026-01-28Class IIPROCESSING DEFECT
Edan iM3s vital signs monitors recalled for cybersecurity vulnerabilities
What this means
Edan Diagnostics recalled certain iM3s series vital signs monitors (models iM3s, iM3As, iM3Bs, iHM3s) due to potential cybersecurity issues identified by the FDA. These monitors measure patient vital signs in clinical settings. The recall affects 136 devices with specific serial numbers distributed across the U.S. and Mexico.
- Check if your device matches a recalled serial number listed in the FDA notice
- Contact Edan Diagnostics or your equipment supplier for instructions
- Do not discard the device; await guidance on remediation or replacement
- Continue using the device only if you have received clearance from the manufacturer
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
All ages
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
136
Manufactured in
9833 Pacific Heights Blvd, San Diego, CA, United States
Products
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital signs monitors including iM3s/iM3As/iM3Bs/iHM3s are intended to be used for measuring, storing, reviewing of, and generating prompts for multiple physiological parameters of adults and pediatrics. Component: No
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1144-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.