HIGH

EDAN Recalls Fetal & Maternal Monitors Over Cybersecurity Risks

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

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

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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560156-M17B10630021 560156-M17B10630022 560156-M17B10630023 560156-M17B10630024 560156-M17B10630025 560156-M17B10630026 560156-M17B10630027 560156-M17B10630028 560156-M17B10630029 560156-M17B10630030 560156-M17B10630031 560156-M17B10630032 560156-M17B10630033 560156-M17B10630034 560156-M17B10630035 560156-M17B10630036 EDAN Model: F9 Express UDI-DI code: 06944413800441 Serial/Lot Numbers: 560157-M15A03570001 460418-M15B07460001 460418-M16501740001 460418-M16405110001 460418-M16405110002 460418-M16405110003 460418-M16405110004 460418-M16405110005 460418-M16405110006 460418-M16405110007 460418-M16405110008 460418-M16405110009 460418-M16405110010 460418-M16405110011 460418-M16405110012 460288-M16702150001 460418-M16705790001 460418-M16705790002 460418-M16705790003 460418-M16705790004 460418-M16A07660001 460418-M16B00420001 460418-M16B00420002 460418-M16B00420003 460418-M16B00420004 460418-M16B00420005 460418-M16B00420006 460077-M16B04200001 460077-M16B04200002 460077-M16B04200003 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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
Recall Status
ACTIVE

Related Recalls

HIGH

Fresenius Kabi Vancomycin Injection Recalled Over Sterility Concerns

Fresenius Kabi Compounding recalled its vancomycin HCl injection on February 5, 2026, due to a lack of assurance of sterility. This Class II recall affects all lots distributed nationwide. Healthcare providers and consumers must stop using the product immediately.

Fresenius Kabi Compounding
Lack of
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HIGH

Fresenius Kabi Compounding Issues Recall of Vancomycin Injection

Fresenius Kabi Compounding recalled 1,578 bags of vancomycin HCl injection on February 5, 2026. The company cited a lack of assurance of sterility as the reason for the recall. Healthcare providers and consumers should stop using the product immediately.

Fresenius Kabi Compounding
Lack of
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HIGH

Pro Numb Tattoo Numbing Spray Recalled Due to cGMP Violations

Pro Numb Tattoo Numbing Spray was recalled on February 2, 2026 due to cGMP deviations. The product, containing 4% lidocaine, is distributed by Pro Numb Tattoo Numbing Spray LLC. Consumers should stop using it immediately and contact the company for further guidance.

PRO NUMB SENSITIVE SKIN
cGMP deviations
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