FDAFDA · Food and drugs·Recall number Z-1140-2026
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
Published January 28, 2026 · Recall initiated: October 24, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Edan Diagnostics
- Distributor
- 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.
- Lot
- EDAN Model: F3 UDI-DI code: 06944413800847 Serial/Lot Code: 460085-M16105760001 460085-M16105760002 460085-M16105760003 460085-M16105760004 460085-M16105760005 460085-M16105760006 460085-M16105760007 460085-M16105760008 460085-M16105760009 460085-M16105760010 460085-M16105760011 460085-M16105760012 460085-M16105760013 460085-M16105760014 460085-M16105760015 460085-M16105760016 460085-M16105760017 460085-M16105760018 460085-M16105760019 460085-M16105760020 460085-M16105760021 460085-M16105760022 460085-M16105760023 460085-M16105760024 460085-M16105760025 460085-M16105760026 460085-M16105760027 460085-M16105760028 460085-M16105760029 460085-M16105760030 460085-M16105760031 460085-M16105760032 460085-M16105760033 460085-M16105760034 460085-M16105760035 460085-M16105760036 460085-M16105760037 460085-M16105760038 460085-M16105760039 460085-M16105760040 460085-M16105760041 460085-M16105760042 460085-M16105760043 460085-M16105760044 460085-M16105760045 460085-M16105760046 460085-M16105760047 460085-M16105760048 460085-M16105760049 460085-M16105760050 460085-M16105760051 460085-M16105760052 460085-M16105760053 460085-M16803010001 460085-M16803010002 460085-M16803010003 460085-M16803010004 460085-M16803010005 460085-M16803010006 460085-M16803010007 460085-M16803010008 460085-M16803010009 460085-M16803010010 460085-M16803010011 460085-M16803010012 460085-M16803010013 460085-M16803010014 460085-M16803010015 460085-M16803010016 460085-M16803010017 460085-M16803010018 460085-M16803010019 460085-M16803010020 460085-M16803010021 460085-M16803010022 460085-M16803010023 460085-M16803010024 460085-M16803010025 460085-M16803010026 460085-M16803010027 460085-M16803010028 460085-M16803010029 460085-M16803010030 460085-M16803010031 460085-M16803010032 460085-M16803010033 460085-M16803010034 460085-M16803010035 460085-M16803010036 460085-M16803010037 460085-M16803010038 460085-M16803010039 460085-M16803010040 460085-M16803010041 460085-M16803010042 460085-M16803010043 460085-M16803010044 460085-M16803010045 460085-M16803010046 460085-M16803010047 460085-M16803010048 460085-M16803010049 460085-M16803010050 460085-M16803010051 460085-M16803010052 460085-M16803010053 460085-M16803010054 460085-M16803010055 460085-M16803010056 460085-M16803010057 460085-M16803010058 460085-M16803010059 460085-M16803010060 460085-M16803010061 460085-M16803010062 460085-M16803010063 460085-M16803010064 460085-M16A04870001 460085-M16A04870002 460085-M16A04870003 460085-M16A04870004 460085-M16A04870005 460085-M16A04870006 460085-M16A04870007 460085-M16A04870008 460085-M16A04870009 460085-M16A04870010 460085-M16A04870011 460085-M16A04870012 460085-M16A04870013 460085-M16A04870014 460085-M16A04870015 460085-M16A04870016 460085-M16A04870017 460085-M16A04870018 460085-M16A04870019 460085-M16A04870020 460085-M16A04870021 460085-M16A04870022 460085-M16A04870023 460085-M16A04870024 460085-M16A04870025 460085-M16A04870026 460085-M16A04870027 460085-M16A04870028 460085-M16A04870029 460085-M16A04870030 460085-M16A04870031 460085-M16A04870032 460085-M16A04870033 460085-M16A04870034 460085-M16A04870035 460085-M16A04870036 460085-M16A04870037 460085-M16A04870038 460085-M16A04870039 460085-M16A04870040 460085-M16A04870041 460085-M16A04870042 460085-M16A04870043 460085-M16A04870044 460085-M16A04870045 460085-M16A04870046 460085-M16A04880001 460085-M16A04880002 460085-M16A04880003 460085-M16A04880004 460085-M16A04880005 460085-M16A04880006 460085-M16A04880007 460085-M16A04880008 460085-M16A04880009 460085-M16A04880010 460085-M16A04880011 460085-M16A04880012 460085-M16A04880013 460085-M16A04880014 460085-M16A04880015 460085-M16A04880016 460085-M16A04880017 460085-M16A04880018 460085-M16A04880019 460085-M16A04880020 460085-M16A04880021 460085-M16A04880022 460085-M16A04880023 460085-M16A04880024 460085-M16A04880025 460085-M16A04880026 460085-M16A04880027 460085-M16A04880028 460085-M16A04880029 460085-M16A04880030 460085-M16A04880031 460085-M16A04880032 460085-M16A04880033 460085-M16A04880034
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.