Reported Jan 28, 2026 · Ongoing
Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express Product…
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 &
- Maternal Monitor Model/Catalog Number
F6F9F6 Express
- F9 Express 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 ModelF9
- UDI-DI code06944413800434
- Serial/Lot Numbers
1,312 of 1,312 codes
460430-M16105660001460430-M16700280001460475-M16605590001460475-M16605590002460475-M16605590003460475-M16605590004460475-M16806530001460475-M16806530002460476-M16B07550001460476-M16B07550002460476-M16B07550003460476-M17402630001460476-M17402630002460476-M17402630003460476-M17402630004460476-M17402630005460476-M17607650001460476-M17607650002460476-M17607650003460476-M17607650004460476-M17607650005460476-M17607650006460476-M17607650007460476-M17607650008460476-M17607650009460476-M17607650010460517-M16804200001460688-M17A07770001460688-M17A07770002460688-M17A07770003460723-M17904190001460945-M18200660001460945-M18200660002460945-M18200660003460945-M18200660004460945-M18200660005460945-M18200660006460945-M18200660007460945-M18200660008460945-M18200660009460945-M18200660010460945-M18200660011460945-M18200660012460945-M18200660013460945-M18200660014460945-M18200660015460945-M18200660016460945-M18200660017460945-M18200660018460945-M18200660019460945-M18200660020460945-M18200660021460945-M18200660022460945-M18200660023460945-M18200660024460945-M18200660025460945-M18200660026460945-M18200660027460945-M18200660028460945-M18200660029
- EDAN ModelF9
- Express UDI-DI code06944413800441
- Serial/Lot Numbers
280 of 280 codes
560157-M15A03570001460418-M15B07460001460418-M16501740001460418-M16405110001460418-M16405110002460418-M16405110003460418-M16405110004460418-M16405110005460418-M16405110006460418-M16405110007460418-M16405110008460418-M16405110009460418-M16405110010460418-M16405110011460418-M16405110012460288-M16702150001460418-M16705790001460418-M16705790002460418-M16705790003460418-M16705790004460418-M16A07660001460418-M16B00420001460418-M16B00420002460418-M16B00420003460418-M16B00420004460418-M16B00420005460418-M16B00420006460077-M16B04200001460077-M16B04200002460077-M16B04200003460077-M16B04200004460418-M16B13700001460418-M16B13700002460418-M16C08190001460418-M16C08190004460418-M16C08190003460418-M16C08190005460418-M16C08190002460418-M17107420001460418-M17107420002460418-M17312480001560039-M17906650005560039-M17906650001560039-M17906650004560039-M17906650003560039-M17906650002460246-M15300540001460497-M18313120002460497-M18313120001560039-M18706210004560039-M18706210003560039-M18706210001560039-M18706210002560039-M19109690001560039-M19109690009560039-M19109690012560039-M19109690002560039-M19109690003560039-M19109690004560039-M19109690015
- EDAN ModelF6
- UDI-DI code06944413800458
- Serial/Lot Numbers5
560177-M15A03580001560177-M15A03580002560177-M15A03580003560198-M15A03590001560198-M15A03590002560198-M15A03590003560198-M15A03590004560198-M15A03590005560202-M15A03690001560202-M15A03690002560202-M15A03690003560202-M15A03690004560202-M15A03690005560202-M15A03690006560202-M15A06640001560202-M15A06640002560202-M15A06640003560202-M15A06660001560202-M15A06660002560202-M15A06660003560202-M15A06660004560202-M15A06660005560202-M15A06660006560202-M15A06660007560202-M15A06660008560202-M15A06660009560202-M15A06660010560202-M15A06660011
- Amount recalled
- 3518
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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