Recall archive / FDA device enforcement
Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedsid... — FDA record Z-1140-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 24, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- 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.
- Classification
- Class II
- Recalling firm
- Edan Diagnostics
- Quantity
- 3721
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1140-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 460085-M16A04880035 460085-M16A04880036 460085-M16A04880037 460085-M16A04880038 460085-M16A04880039 460085-M16A04880040 460085-M16A04880041 460085-M16A04880042 460085-M16A04880043 460085-M16A04880044 460085-M16A04880045 460085-M16A04880046 460085-M16A04880047 460085-M16A04880048 460085-M16A04880049 460085-M16A04880050 460085-M17107980001 460085-M17107980002 460085-M17107980003 460085-M17107980004 460085-M17107980005 460085-M17107980006 460085-M17107980007 460085-M17107980008 460085-M17107980009 460085-M17107980010 460085-M17107980011 460085-M17107980012 460085-M17107980013 460085-M17107980014 460085-M17107980015 460085-M17602680001 460085-M17602680002 460085-M17602680003 460085-M17602680004 460085-M17602680005 460085-M17602680006 460085-M17602680007 460085-M17602680008 460085-M17602680009 460085-M17602680010 460085-M17602680011 460085-M17602680012 460085-M17602680013 460085-M17602680014 460085-M17602680015 460085-M17602680016 460085-M17602680017 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460403-M16811370013 460403-M16811370014 460403-M16811370015 460403-M16811370016 460403-M16811370017 460403-M16811370018 460403-M16811370019 460403-M16811370020 460403-M16811370021 460403-M16811370022 460403-M16811370023 460403-M16811370024 460403-M16811370025 460403-M16811370026 460403-M16811370027 460403-M16811370028 460403-M16811370029 460403-M16811370030 460403-M16811370031 460403-M16811370032 460403-M16811370033 460403-M16811370034 460403-M16811370035 460403-M16811370036 460403-M16811370037 460403-M16811370038 460403-M16811370039 460403-M16811370040 460403-M16811370041 460403-M16811370042 460403-M16811370043 460403-M16811370044 460403-M16811370045 460403-M16811370046 460403-M16811370047 460403-M16811370048 460403-M16811370049 460403-M16811370050 460403-M16811370051 460403-M16811370052 460403-M16811370053 460403-M16811370054 460403-M16811370055 460403-M16811370056 460403-M17205680001 460403-M17205680002 460403-M17205680003 460403-M17205680004 460403-M17205680005 460403-M17205680006 460403-M17205680007 460403-M17205680008 460403-M17205680009 460403-M17205680010 460403-M17205680011 460403-M17205680012 460403-M17205680013 460403-M17205680014 460403-M17205680015 460403-M17205680016 460403-M17205680017 460403-M17205680018 460403-M17205680019 460403-M17205680020 460403-M17205680021 460403-M17205680022 460403-M17205680023 460403-M17205680024 460403-M17205680025 460403-M17205680026 460403-M17205680027 460403-M17205680028 460403-M17205680029 460403-M17205680030 460403-M17205680031 460403-M17205680032 460403-M17205680033 460403-M17205680034 460403-M17205680035 460403-M17205680036 460403-M17205680037 460403-M17205680038 460403-M17205680039 460403-M17205680040 460403-M17205680041 460403-M17205680042 460403-M17205680043 460403-M17205680044 460403-M17205680045 460403-M17205680046 460403-M17205680047 460403-M17205680048 460403-M17205680049 460403-M17205680050 460403-M17205690001 460403-M17205690002 460403-M17205690003 460403-M17205690004 460403-M17205690005 460403-M17205690006 460403-M17205690007 460403-M172056900... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jan 28, 2026
- Recall initiation date
- Oct 24, 2025
- Center classification date
- Jan 22, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.