What should I do if I have an EDAN iM3 monitor?

Stop using the device immediately and follow the recall instructions provided by the manufacturer.

How can I return the recalled monitor?

Contact EDAN Diagnostics directly for instructions on how to return your monitor and obtain a refund.

Are there any reported injuries related to this recall?

No injuries or incidents have been reported regarding the cybersecurity issues with the iM3 monitor.

What is the reason for the recall?

The recall was issued due to potential cybersecurity vulnerabilities that could compromise patient data and device functionality.

Where can I find more information about the recall?

Visit the EDAN Diagnostics website or contact their customer service for more details about the recall.

How do I know if my monitor is affected?

Check the model and serial numbers of your monitor against the recall list provided by EDAN Diagnostics.

Will I get a full refund for my returned monitor?

Yes, you are entitled to a full refund regardless of whether you have a receipt.

Can I keep using the monitor until I get a replacement?

No, you should stop using the device immediately as it may pose cybersecurity risks.

How long will it take to process my refund?

Typically, refunds are processed within 4-8 weeks after the returned device is received.

What if I have further questions about the recall?

You can reach out to EDAN Diagnostics directly for any additional questions or concerns.

HIGHOctober 24, 2025

EDAN Vital Signs Monitor Recalled Over Cybersecurity Concerns

EDAN recalled 11,987 iM3 Vital Signs Monitors on October 24, 2025 due to potential cybersecurity risks. The recall affects devices distributed across the United States 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 product is the EDAN Vital Signs Monitor model iM3, capable of measuring blood pressure, oxygen saturation, pulse rate, and temperature. It has three modes: Monitor, Spot, and Round. The devices were sold worldwide, including in California, Kentucky, Puerto Rico, Florida, Connecticut, Illinois, Pennsylvania, Rhode Island, North Carolina, New York, Louisiana, Texas, Michigan, and Mexico.

The Hazard

The recall was initiated following an FDA It Has Come to Our Attention Letter concerning potential cybersecurity vulnerabilities in the iM3 devices. These vulnerabilities may compromise patient data and device functionality.

Reported Incidents

No injuries or incidents have been reported due to the cybersecurity issues associated with this recall.

What to Do

Patients and healthcare providers should stop using the device immediately. Follow the manufacturer's recall instructions and contact EDAN Diagnostics or your healthcare provider for further guidance.

Contact Information

Consumers may contact EDAN Diagnostics for more information at 1-800-XXX-XXXX or visit their website.

Key Facts

11,987 units recalled
Sold across U.S. and Mexico
Potential cybersecurity vulnerabilities
No reported injuries or incidents

View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH

Severity Score

7/ 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: iM3 UDI-DI code: 06944413808812 Serial/Lot Numbers: 261436-M19B06650005 261436-M19B06650003 261436-M19B06660007 261436-M19B06650002 261436-M19B06660001 261436-M19B06660004 261436-M19B06650001 261436-M19B06660008 261436-M19B06660003 261436-M19B06660002 261436-M19B06660006 261436-M19B06650004 261436-M19B06660010 261436-M19B06660005 261436-M19B06660009 261436-M19C16980011 261436-M19C16980013 261436-M19C16980002 261436-M19C16980004 261436-M19C16980006 261436-M19C16980012 261436-M19C16980009 261436-M19C16980010 261436-M19C16980015 261436-M19C16980003 261436-M19C16980005 261436-M19C16980008 261436-M19C16980001 261436-M19C16980007 261436-M19C16980014 261436-M20707940016 261436-M20707940014 261436-M20707940008 261436-M20707940002 261436-M20707940020 261436-M20707940006 261436-M20707940004 261436-M20707940001 261436-M20707940012 261436-M20707940018 261436-M20707940009 261436-M20707940010 261436-M20707940011 261436-M20707940003 261436-M20707940005 261436-M20707940013 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263126-M24817920014 263126-M24817920001 263126-M24816510017 263126-M24816510002 263126-M24719110034 263126-M24817920017 263123-M24816500014 263123-M24816500019 263126-M24817920007 263126-M24817920004 263126-M24816510014 263126-M24816510013 263123-M24816500018 263126-M24816510011 263126-M24817920009 263126-M24816510005 263123-M24816500020 263126-M24817920015 263126-M24816510006 263126-M24817920002 263126-M24719110032 263126-M24817920006 263126-M24817920013 263126-M24719110019 263125-M24708030015 263125-M24716440005 263123-M24816500015 263123-M24816500003 263125-M24708030020 263125-M24716440017 263125-M24716440006 263126-M24719110005 263125-M24716440020 263126-M24816510016 263126-M24719110028 263126-M24817920019 263126-M24817920018 263126-M24816510019 263126-M24816510012 263126-M24816510020 263126-M24816510010 263126-M24817920005 263125-M24708030013 263125-M24716440016 263125-M24708030001 263125-M24716440010 263125-M24716440004 263125-M24716440003 263125-M24716440001 263125-M24716440002 263126-M24817910015 263126-M24817910009 263126-M24817910016 263126-M24817920012 263126-M24817900016 263126-M24817910012 263126-M24817910003 263126-M24817910020 263126-M24817900011 263126-M24817900005 263126-M24817910002 263126-M24817910010 263126-M24817910013 263126-M24817910017 263126-M24817900020 263126-M24817910004 263126-M24817910001 263126-M24817900003 263126-M24817900009 263126-M24817900010 263126-M24817910007 263126-M24817900006 263126-M24817900004 263126-M24817900014 263126-M24817910018 263126-M24817900002 263126-M24817900007 263126-M24817900008 263126-M24817910005 263126-M24817910008 263126-M24817910

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