What should I do if I have an affected EDAN fetal monitor?

Stop using the device immediately and contact Edan Diagnostics or your healthcare provider for recall instructions.

How can I identify if my fetal monitor is affected by the recall?

Check the model number; affected models are F2 and F3. Verify the serial number against the recall list provided by Edan Diagnostics.

What if I experience issues with the monitor during use?

If you encounter any problems while using the device, discontinue use and contact your healthcare provider immediately.

Will I receive a refund for the recalled monitor?

Yes, you should contact Edan Diagnostics for instructions on how to obtain a refund.

Are there any reported injuries from this recall?

No injuries have been reported related to this recall, but there are potential safety concerns due to cybersecurity vulnerabilities.

How does this cybersecurity issue affect the fetal monitor's function?

Cybersecurity vulnerabilities could potentially allow unauthorized access to the device, compromising its safety and effectiveness.

When was this recall issued?

The recall was issued on October 24, 2025, following an FDA notification regarding potential cybersecurity issues.

Where can I find more information about this recall?

More information can be found on the FDA's website or by contacting Edan Diagnostics directly.

What is the classification of this recall?

This recall is classified as Class II, indicating that the device may cause temporary or medically reversible adverse health consequences.

How long will it take to process my refund?

Refund processing times can vary; expect it to take several weeks once your request is submitted.

HIGHOctober 24, 2025

EDAN Fetal Monitors Recalled Due to Cybersecurity Risk

EDAN recalled 3,721 fetal monitors on October 24, 2025, due to potential cybersecurity vulnerabilities. The affected models, F2 and F3, are used to monitor pregnant women and fetuses after 28 weeks of gestation. Healthcare providers must stop using these devices immediately and follow recall instructions.

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 products include EDAN fetal monitors, models F2 and F3. They were distributed in the U.S. states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and in Mexico. The recall affects 3,721 units.

The Hazard

The recall stems from a letter from the FDA regarding potential cybersecurity issues. These vulnerabilities could compromise the safety and effectiveness of the monitors, posing risks to patients.

Reported Incidents

No injuries or incidents have been reported related to this specific recall. However, the potential for cybersecurity breaches raises significant safety concerns.

What to Do

Patients and healthcare providers should stop using the monitors immediately. Contact Edan Diagnostics or your healthcare provider for further instructions on the recall.

Contact Information

For more information, contact Edan Diagnostics at [insert phone number] or visit their website at [insert website].

Key Facts

Recalled models: F2, F3
Total recalled units: 3,721
Affected distribution: U.S. and Mexico
Stop using devices immediately
Contact manufacturer for instructions

View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH

Severity Score

7/ 10

Affected Groups

GENERAL

Injury Types

ELECTRICAL

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeFetal Monitor

Product Details

Brand

Edan Diagnostics

Categories

Health & Personal Care Medical Devices

Model Numbers

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 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461053-M22204670035 461053-M22204670036 461053-M22204670037 461053-M22204670038 461053-M22204670039 461053-M22204670040 461053-M22204670041 461053-M22204670042 461053-M22204670043 461053-M22204670044 461053-M22204670045 461053-M22204670046 461053-M22204670047 461053-M22204670048 461053-M22204670049 461053-M22204670050 461053-M22204680001 461053-M22204680002 461053-M22204680003 461053-M22204680004 461053-M22204680005 461053-M22204680006 461053-M22204680007 461053-M22204680008 461053-M22204680009 461053-M22204680010 461053-M22204680011 461053-M22204680012 461053-M22204680013 461053-M22204680014 461053-M22204680015 461053-M22204680016 461053-M22204680017 461053-M22204680018 461053-M22204680019 461053-M22204680020 461053-M22204680021 461053-M22204680022 461053-M22204680023 461053-M22204680024 461053-M22204680025 461053-M22705590001 461053-M22705590002 461053-M22705590003 461053-M22705590004 461053-M22705590005 461053-M22705590006 461053-M22705590007 461053-M22705590008 461053-M22705590009 461053-M22705590010 461053-M22705590011 461053-M22705590012 461053-M22705590013 461053-M22705590014 461053-M22705590015 461053-M22705590016 461053-M22705590017 461053-M22705590018 461053-M22705590019 461053-M22705590020 461053-M22705590021 461053-M22705590022 461053-M22705590023 461053-M22705590024 461053-M22705590025 461053-M22705590026 461053-M22705590027 461053-M22705590028 461053-M22705590029 461053-M22705590030 461053-M22705590031 461053-M22705590032 461053-M22705590033 461053-M22705590034 461053-M22705590035 461053-M22705590036 461053-M22705590037 461053-M22705590038 461053-M22705590039

Affected States

ALL

Report Date

January 28, 2026

Source Agency

FDA - Medical Devices

Recall Status

ACTIVE

Related Recalls

MEDIUM

Feb 9, 2026

Taro Pharmaceuticals Withdraws Diclofenac Sodium Gel Over Viscosity Issues

Taro Pharmaceuticals announced a market withdrawal of Diclofenac Sodium, Topical Gel, 3% on January 27, 2026. The withdrawal stems from out of specification viscosity results. Healthcare providers and consumers should stop using the product immediately.

CETRORELIX ACETATE

Defective delivery

HIGH

Feb 5, 2026

Fresenius Kabi Compounding Recalls Acyclovir Sodium Injection Due to Sterility Risks

Fresenius Kabi Compounding recalled 1,057 bags of Acyclovir Sodium Injection on February 5, 2026. The recall stems from a lack of assurance of sterility, posing a high health risk. Healthcare providers should cease use immediately and contact the manufacturer for guidance.

Fresenius Kabi Compounding

Lack of

HIGH

Feb 5, 2026

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

HIGH

Feb 5, 2026

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

HIGH

Feb 5, 2026

Fresenius Kabi Compounding Recalls Ketamine Injection for Sterility Risk

Fresenius Kabi Compounding recalled 1,410 bags of ketamine HCl injection on February 5, 2026. The recall stems from a lack of assurance of sterility, posing a high health risk. Healthcare providers and consumers must stop using this product immediately.

Fresenius Kabi Compounding

Lack of

HIGH

Feb 5, 2026

Fresenius Kabi Compounding Recalls Thiamine Injection Over Sterility Risk

Fresenius Kabi Compounding recalled 10,548 bags of thiamine HCl injection on February 5, 2026. The recall follows a lack of assurance of sterility, posing a high health risk. Affected products include several lots expiring between February and May 2026.

Fresenius Kabi Compounding

Lack of

HIGH

Feb 2, 2026

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

HIGH

Feb 2, 2026

Pro Numb Tattoo Numbing Spray Recalled Due to cGMP Deviations

Pro Numb Tattoo Numbing Spray was recalled due to cGMP deviations. The recall affects products distributed nationwide in the USA. Consumers should stop using the spray immediately and contact Pro Numb Tattoo Numbing Spray LLC for guidance.

PRO NUMB

cGMP deviations