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
Reported: January 28, 2026 Initiated: October 24, 2025 #Z-1140-2026
Product Description
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
Reason for Recall
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.
Details
- Recalling Firm
- Edan Diagnostics
- Units Affected
- 3721
- Distribution
- 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.
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Edan Diagnostics. Units affected: 3721.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 28, 2026. Severity: Moderate. Recall number: Z-1140-2026.
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