How do I know if my EDAN fetal monitor is affected by the recall?

Check the model and serial number of your device against the list provided in the recall notice or on the FDA website.

What are the potential risks of using a recalled fetal monitor?

Using a device with cybersecurity vulnerabilities could compromise patient safety and the efficacy of monitoring during pregnancy.

Where can I find the serial number on my EDAN monitor?

The serial number is typically located on the back or bottom of the device. Refer to the user manual for specific instructions.

Can I get a refund for my recalled EDAN monitor?

Yes, follow the return instructions provided by the manufacturer to initiate the refund process.

What if I experience issues with the refund process?

Document any correspondence and contact Edan Diagnostics directly for resolution. If issues persist, consider filing a complaint with the appropriate regulatory body.

Is there a safe alternative to the EDAN fetal monitor?

Look for certified fetal monitoring devices that meet safety standards and have a good track record for reliability.

What is the deadline for returning the recalled monitors?

There is no specified deadline, but it is advisable to return the device as soon as possible to ensure safety.

Will my healthcare provider help with the recall process?

Yes, your healthcare provider should be informed and can assist you with the return process.

Are there any known incidents related to the EDAN monitor recall?

No incidents or injuries have been reported related to this recall, but the company is taking precautionary measures.

HIGHOctober 24, 2025

EDAN Recalls Fetal & Maternal Monitors Over Cybersecurity Risks

Q: What should I do if I have one of the recalled EDAN monitors?

Stop using the device immediately and follow the recall instructions provided by the manufacturer. Contact Edan Diagnostics for further guidance.

EDAN recalled 3,518 fetal and maternal monitors on October 24, 2025, due to potential cybersecurity issues. Affected models include F6, F9, F6 Express, and F9 Express. The recall impacts devices distributed in the U.S. and Mexico.

Quick Facts at a Glance

Recall Date: October 24, 2025
Hazard Level: HIGH
Brand: Edan Diagnostics
Category: Health & Personal Care
Sold At: Multiple Retailers
Geographic Scope: 1 states
At-Risk Groups: GENERAL

Hazard Information

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 You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Edan Diagnostics or your healthcare provider for instructions. Notification method: Letter

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Product Details

The recalled models are the EDAN F6, F9, F6 Express, and F9 Express fetal and maternal monitors. These devices were sold nationwide in states including California, Texas, and New York, as well as in Mexico.

The Hazard

The recall stems from an FDA It Has Come to Our Attention Letter regarding potential cybersecurity vulnerabilities. These issues could compromise the safety and effectiveness of the monitoring devices.

Reported Incidents

No injuries or incidents have been reported in relation to this recall. The company has initiated the recall as a precautionary measure.

What to Do

Patients and healthcare providers must stop using the devices immediately. Follow the manufacturer's instructions for returning the monitors.

Contact Information

For assistance, contact Edan Diagnostics at [contact number not provided] or visit their website at [website not provided].

Key Facts

Recall date: October 24, 2025
Total units recalled: 3,518
Models affected: F6, F9, F6 Express, F9 Express
Distribution: Worldwide, including the U.S. and Mexico
Stop using devices immediately

View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeFetal & Maternal Monitor

Product Details

Brand

Edan Diagnostics

Categories

Health & Personal Care Medical Devices

Model Numbers

EDAN Model: F9 UDI-DI code: 06944413800434 Serial/Lot Numbers: 460430-M16105660001 460430-M16700280001 460475-M16605590001 460475-M16605590002 460475-M16605590003 460475-M16605590004 460475-M16806530001 460475-M16806530002 460476-M16B07550001 460476-M16B07550002 460476-M16B07550003 460476-M17402630001 460476-M17402630002 460476-M17402630003 460476-M17402630004 460476-M17402630005 460476-M17607650001 460476-M17607650002 460476-M17607650003 460476-M17607650004 460476-M17607650005 460476-M17607650006 460476-M17607650007 460476-M17607650008 460476-M17607650009 460476-M17607650010 460517-M16804200001 460688-M17A07770001 460688-M17A07770002 460688-M17A07770003 460723-M17904190001 460945-M18200660001 460945-M18200660002 460945-M18200660003 460945-M18200660004 460945-M18200660005 460945-M18200660006 460945-M18200660007 460945-M18200660008 460945-M18200660009 460945-M18200660010 460945-M18200660011 460945-M18200660012 460945-M18200660013 460945-M18200660014 460945-M18200660015 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560039-M24706730007 560039-M24706730006 560039-M24706730001 560039-M24706730005 560039-M24706730003 560039-M24A17700001 560039-M24A17700002 560039-M24A17700007 560039-M24A17700008 560039-M24A17700009 560039-M24A17700003 560039-M24A17700004 560039-M24A17700005 560039-M24A17700006 560039-M24C01220001 560039-M24C01220002 560039-M24C01220005 560039-M24C01220018 560039-M24C01220019 560039-M24C01220007 560039-M24C01220009 560039-M24C01220013 560039-M24C01220014 560039-M24C01220016 560039-M24C01220003 560039-M24C01220004 560039-M24C01220006 560039-M24C01220010 560039-M24C01220017 560039-M24C01220008 560039-M24C01220011 560039-M24C01220012 560039-M24C01220015 560039-M24C01220020 560039-M24C15030003 560039-M24C15030011 560039-M24C15030004 560039-M24C15030005 560039-M24C15030001 560039-M24C15030006 560039-M24C15030009 560039-M24C15030010 560039-M24C15030002 560039-M24C15030007 560039-M24C15030008 560039-M24C18150001 461291-M25623120002 461291-M25623120004 461291-M25623120001 461291-M25623120003 EDAN Model: F6 UDI-DI code: 06944413800458 Serial/Lot Numbers: 560177-M15A03580001 560177-M15A03580002 560177-M15A03580003 560198-M15A03590001 560198-M15A03590002 560198-M15A03590003 560198-M15A03590004 560198-M15A03590005 560202-M15A03690001 560202-M15A03690002 560202-M15A03690003 560202-M15A03690004 560202-M15A03690005 560202-M15A03690006 560202-M15A06640001 560202-M15A06640002 560202-M15A06640003 560202-M15A06660001 560202-M15A06660002 560202-M15A06660003 560202-M15A06660004 560202-M15A06660005 560202-M15A06660006 560202-M15A06660007 560202-M15A06660008 560202-M15A06660009 560202-M15A06660010 560202-M15A06660011 5

Affected States

ALL

Report Date

January 28, 2026

Source Agency

FDA - Medical Devices

Recall Status

ACTIVE

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PRO NUMB SENSITIVE SKIN

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PRO NUMB

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