What should I do if I own an EDAN M3 Vital Signs Monitor?

Stop using the monitor immediately and contact Edan Diagnostics for further instructions.

What are the risks associated with the EDAN M3 recall?

The recall is due to potential cybersecurity issues that can affect device functionality and patient data security.

How can I find out if my EDAN M3 monitor is affected by the recall?

Check the model number and serial numbers against the recall list provided by Edan Diagnostics.

Will I receive a refund for my recalled monitor?

Refunds or replacements will be processed as per the manufacturer's guidelines after you contact them.

What should I document if I experience issues with the monitor?

Keep records of your purchase, any communications with Edan Diagnostics, and document any issues encountered with the device.

Is there a risk of injury from using the EDAN M3 monitor?

While no injuries have been reported, the cybersecurity risks could potentially lead to mismanagement of patient data.

What is the classification of this recall?

The FDA has classified this recall as Class II, indicating a moderate risk to health.

How can I contact Edan Diagnostics for more information?

You can reach Edan Diagnostics through their customer service at 800-XXX-XXXX or visit their official website.

Are there any alternative products to consider?

Consider using automatic blood pressure monitors, pulse oximeters, or digital thermometers as alternatives.

What if I have further concerns about the recall?

If you have concerns, contact your healthcare provider or report to the FDA.

HIGHOctober 24, 2025

EDAN Vital Signs Monitor Recalled Over Cybersecurity Issues

EDAN recalled 13,934 M3 Vital Signs Monitors on October 24, 2025 due to potential cybersecurity issues. The recall affects devices distributed in multiple U.S. states and Mexico. Healthcare professionals must stop using the device immediately and follow manufacturer 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 product is the EDAN M3 Vital Signs Monitor. It was sold across various locations worldwide, including the U.S. states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, and MI. The quantity recalled is 13,934 units.

The Hazard

Cybersecurity vulnerabilities pose potential risks to patient data and device functionality. These issues could hinder the monitor's ability to accurately track vital signs.

Reported Incidents

No specific incidents of injury or death have been reported related to this recall. However, the potential for misuse due to cybersecurity risks exists.

What to Do

Stop using the EDAN M3 Vital Signs Monitor immediately. Contact Edan Diagnostics or your healthcare provider for detailed instructions and next steps.

Contact Information

For more information, contact Edan Diagnostics. Call their customer service at 800-XXX-XXXX or visit their website.

Key Facts

Recalled model: EDAN M3 Vital Signs Monitor
Recall date: October 24, 2025
Total units recalled: 13,934
Affected regions: U.S. and Mexico
Cybersecurity issues identified

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 TypeVital Signs Monitor

Product Details

Brand

Edan Diagnostics

Categories

Health & Personal Care Medical Devices

Model Numbers

EDAN Model: M3 UDI-DI code: 06944413800618 Serial/Lot Number: 302050-M16200560001 302050-M16200560002 302089-M16203830017 302089-M16203830006 302089-M16203830020 302127-M15B11010006 302127-M16203840001 302127-M16203840002 302127-M16203840003 302127-M16203840004 302127-M16203840005 302127-M16203840006 302127-M16203840007 302127-M16203840008 302127-M16203840009 302127-M16203840010 302127-M16203840011 302127-M16203840012 302127-M16203840013 302127-M16203840014 302089-M16203830019 302089-M16203830018 302089-M16203830016 302089-M16203830015 302089-M16203830014 302089-M16203830013 302089-M16203830012 302089-M16203830011 302089-M16203830010 302089-M16203830008 302089-M16203830007 302089-M16203830005 302089-M16203830004 302089-M16203830009 302050-M16203850007 302089-M16203830003 302050-M16203850001 302089-M16203830002 302089-M16203830001 302050-M16203850010 302050-M16203850009 302050-M16203850008 302050-M16203850002 302050-M16203850006 302050-M16203850005 302050-M16203850004 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360124-M20914830075 360124-M20914830054 360124-M20914830044 360124-M20914830037 360124-M20914830033 360124-M20914830024 360124-M20914820053 360124-M20914820039 360124-M20914820043 360124-M20914830003 360124-M20914830007 360124-M20914830029 360124-M20914830030 360124-M20914830060 360124-M20914830072 360124-M20914830074 360124-M20914830076 360124-M20914830085 360124-M20914830089 360124-M20914830041 360124-M20914820051 360124-M20914830093 360124-M20914820047 360124-M20914820045 360124-M20914820042 360124-M20914820034 360124-M20914820027 360124-M20914820026 360124-M20914820025 360124-M20914820018 360124-M20914820012 360124-M20914820002 360124-K20900630003 360124-M20914830100 360124-M20914830099 360124-M20914830095 360124-M20914830086 360124-M20914830084 360124-M20914830071 360124-M20914830067 360124-M20914830008 360124-M20914830048 360124-M20914830050 360124-M20914830058 360124-M20914830063 360124-M20914830023 360124-M20914830027 360124-M20914830031 360124-M20914830040 360124-M20914830042 360124-M20914830046 360124-M20914830019 360124-M20914830052 360124-M20914830061 360124-M20914830083 360124-M20914820001 360124-M20914820008 360124-M20914820011 360124-M20914820022 360124-M20914830056 360124-M20914820046 360124-M20914830015 360124-M20914830005 360124-M20914830009 360124-M20914830097 360124-M20914830038 360124-M20A11080008 360124-M20A11080096 360124-M20A11080089 360124-M20A11080082 360124-M20A11080081 360124-M20A11080080 360124-M20A11080076 360124-M20A11080065 360124-M20A11080064 360124-M20A11080058 360124-M20A11080047 360124-M20A11080040 360124-M20A11080023 360124-M20A11080016 360124-M20A11080077 360124-M20A11080063 360124-M20A11080055 360124-M20A11080054 360124-M20A11080049 360124-M20A11080042 360124-M20A11080041 360124-M20A11080033 360124-M20A11080025 360124-M20A11080024 360124-M20A11080003 360124-M20A11080087 360124-M20A11080068 360124-M20A11080059 360124-M20A11080052 360124-M20A11080013 360124-M20A11080046 360124-M20A11080015 360124-M20A11080029 360124-M20A11080097 360124-M20A11080090 360124-M20A11080088 360124-M20A11080071 360124-M20A11080070 360124-M20A11080053 360124-M20A11080035 360124-M20A11080034 360124-M20A11080028 360124-M20A11080005 360124-M20A11080004 360124-M20A11080100 360124-M20A11080099 360124-M20A11080092 360124-M20A11080091 360124-M20A11080085 360124-M20A11080084 360124-M20A11080083 360124-M20A11080079 360124-M20A11080072 360124-M20A11080066 360124-M20A11080048 360124-M20A11080044 360124-M20A11080038 360124-M20A11080022 360124-M20A11080036 360124-M20A11080017 360124-M20A11080010 360124-M20A11080026 360124-M20A11080019 360124-M20A11080012 360124-M20A1108001

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