Reported Jan 28, 2026 · Ongoing
Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside…
Edan Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edan Diagnostics · 9833 Pacific Heights Blvd · San Diego, CA · 92121-4707
Is this the product you have?
- Brand NameEDAN
- Product NameFetal
- Monitor Model/Catalog NumberF2
- F3 Product DescriptionThe 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
- ComponentNo
- Lot codes and dates
- EDAN ModelF3
- UDI-DI code06944413800847
- Serial/Lot Code
1,627 of 1,627 codes
460085-M16105760001460085-M16105760002460085-M16105760003460085-M16105760004460085-M16105760005460085-M16105760006460085-M16105760007460085-M16105760008460085-M16105760009460085-M16105760010460085-M16105760011460085-M16105760012460085-M16105760013460085-M16105760014460085-M16105760015460085-M16105760016460085-M16105760017460085-M16105760018460085-M16105760019460085-M16105760020460085-M16105760021460085-M16105760022460085-M16105760023460085-M16105760024460085-M16105760025460085-M16105760026460085-M16105760027460085-M16105760028460085-M16105760029460085-M16105760030460085-M16105760031460085-M16105760032460085-M16105760033460085-M16105760034460085-M16105760035460085-M16105760036460085-M16105760037460085-M16105760038460085-M16105760039460085-M16105760040460085-M16105760041460085-M16105760042460085-M16105760043460085-M16105760044460085-M16105760045460085-M16105760046460085-M16105760047460085-M16105760048460085-M16105760049460085-M16105760050460085-M16105760051460085-M16105760052460085-M16105760053460085-M16803010001460085-M16803010002460085-M16803010003460085-M16803010004460085-M16803010005460085-M16803010006460085-M16803010007
- Amount recalled
- 3721
This recall covers 16 products
The agency filed one notice per product. You are reading one of them; the other 15 are below.
3 more are in the archive.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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