FDA-Device2026-01-28Class IIPROCESSING DEFECT
Edan fetal and maternal monitors recalled for cybersecurity vulnerabilities
OTHERNationwide distribution
Check your Edan fetal monitor model
Edan Diagnostics fetal and maternal monitors (models F6, F9, F6 Express, F9 Express) may have cybersecurity vulnerabilities that could potentially allow unauthorized access to the device. The FDA identified these issues and asked the company to address them. No injuries have been reported.
- Check if your monitor matches one of the affected serial numbers listed by the FDA
- Contact your healthcare facility or Edan Diagnostics for guidance on updates or replacement
- Do not stop using the device without consulting your healthcare provider
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.
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
3518
Manufactured in
9833 Pacific Heights Blvd, San Diego, CA, United States
Products
Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. Component: No
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1141-2026Don't want to check this manually?
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