FDA-Device2026-01-28Class IIPROCESSING DEFECT
Edan Diagnostics F2 and F3 fetal monitors recalled for cybersecurity vulnerabilities
OTHERNationwide distribution
Check your Edan fetal monitor model and serial number
The FDA identified potential cybersecurity issues with Edan Diagnostics fetal and maternal monitors (models F2 and F3). These bedside monitors are used during pregnancy and labor to track the health of pregnant women and their fetuses. The manufacturer has been notified and is working with the FDA to address the vulnerabilities.
- Check if your facility uses an Edan F2 or F3 fetal monitor by verifying the model number on the device
- Compare your device's serial number to the affected lot codes listed in the recall notice
- Contact Edan Diagnostics or your hospital's medical device team for guidance on cybersecurity updates or replacements
- Do not discontinue use of the monitor without consulting your healthcare provider or device manufacturer
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
3721
Manufactured in
9833 Pacific Heights Blvd, San Diego, CA, United States
Products
Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 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-1140-2026Don't want to check this manually?
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