What should I do if I own an EDAN Patient Monitor?

Immediately cease using the device. Contact Edan Diagnostics for instructions on how to return the monitor for a refund.

What models are affected by the EDAN recall?

The recall affects models iM50, iM60, iM70, and iM80 of the EDAN Patient Monitor series.

Is there a risk of injury with the EDAN Patient Monitors?

There have been no reported injuries related to this recall, but potential cybersecurity vulnerabilities pose a risk.

Where can I find the model number on my EDAN Patient Monitor?

The model number can typically be found on the back or bottom of the device. Look for a label that includes the product name or model number.

How long will it take to get a refund for the recalled monitor?

Refund processing typically takes 4-6 weeks after the manufacturer receives the returned device.

Can I continue to use my EDAN monitor if it seems to work fine?

No. You should stop using the device immediately due to potential cybersecurity issues.

How will I be notified if my monitor is affected?

Edan Diagnostics will send out notifications via letter to affected customers.

What if I can't find my receipt for the EDAN monitor?

You are still entitled to a full refund regardless of whether you have the original receipt.

What should I document regarding the EDAN recall?

Keep records of your communication with Edan Diagnostics, including any return shipping receipts and tracking information.

What are my rights in case of unresponsive customer service?

If Edan Diagnostics does not respond, you can file a complaint with the FDA or seek legal advice.

HIGHOctober 24, 2025

EDAN Patient Monitors Recalled Over Cybersecurity Risks

EDAN recalled 14,550 Patient Monitors on October 24, 2025, due to potential cybersecurity vulnerabilities. The affected models include iM50, iM60, iM70, and iM80. Healthcare providers should stop using these devices immediately and follow the manufacturer's instructions for remedy.

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 recall includes EDAN Patient Monitors models iM50, iM60, iM70, and iM80. These monitors are capable of continuous monitoring of physiological parameters. They were distributed worldwide, including across several U.S. states and Mexico.

The Hazard

The recall stems from an FDA It Has Come to Our Attention Letter regarding potential cybersecurity issues. These vulnerabilities could impact the device's performance and safety.

Reported Incidents

There have been no reported injuries or deaths associated with this recall. The risk level is classified as high due to the potential implications of cybersecurity vulnerabilities.

What to Do

Stop using the affected EDAN Patient Monitors immediately. Contact Edan Diagnostics or your healthcare provider for further instructions on how to proceed.

Contact Information

For more information, contact Edan Diagnostics directly. Visit their official website or call their customer service for assistance.

Key Facts

Recalled models: iM50, iM60, iM70, iM80
Quantity recalled: 14,550 units
Distribution: U.S. Nationwide and Mexico
Classification: Class II recall

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 TypePatient Monitor

Product Details

Brand

Edan Diagnostics

Categories

Health & Personal Care Medical Devices

Model Numbers

EDAN Model: iM50 UDI-DI code: 06944413801622 Serial/Lot Numbers: 002327-M16803350001 002327-M16803350002 360069-M17707110001 333109-M16203920004 333109-M16203920005 333136-M16203910001 333136-M16203910002 333136-M16203910003 333136-M16203910004 333136-M16203910006 333136-M16203910007 333136-M16203910008 333136-M16203910009 333136-M16203910010 333136-M16203910005 333109-M16203920003 333109-M16203920002 333109-M16203920001 333109-M16802350004 333109-M16802350005 333109-M16802350006 333109-M16802350007 333109-M16802350008 333136-M16802360001 333136-M16802360002 333136-M16802360003 333136-M16802360004 333109-M16802350003 333136-M16802360005 333109-M16802350002 333109-M16802350001 333136-M16810700002 333136-M16810700003 333136-M16810700004 333136-M16810700005 333136-M16810700001 333136-M16A02590001 333136-M16A02590002 333136-M16A02590005 333136-M16A02590004 333136-M16A02590003 333136-M16A02590006 333136-M16A02590007 333136-M16A02590008 333136-M16A02590009 333136-M16A02590010 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333153-M17101610036 333153-M17101610031 333153-M17101610017 333153-M17101610032 333153-M17101610037 333153-M17101610013 333153-M17101610027 333153-M17101610028 333153-M17101610029 333153-M17101610030 333153-M17101610024 333153-M17101610016 333153-M17101610010 333153-M17101610004 333152-M17305500001 333152-M17305500007 333152-M17305500003 333152-M17305500002 333152-M17305500006 333152-M17305500005 333152-M17305500009 333152-M17305500008 333152-M17305500010 333152-M17305500004 333153-M17400810004 333153-M17400810005 333153-M17400810013 333153-M17400810011 333153-M17400810006 333153-M17400810015 333153-M1740081

Affected States

ALL

Report Date

January 28, 2026

Source Agency

FDA - Medical Devices

Recall Status

ACTIVE

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MEDIUM

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CETRORELIX ACETATE

Defective delivery

HIGH

Feb 5, 2026

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Lack of

HIGH

Feb 5, 2026

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Fresenius Kabi Compounding

Lack of

HIGH

Feb 5, 2026

Fresenius Kabi Compounding Issues Recall of Vancomycin Injection

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Fresenius Kabi Compounding

Lack of

HIGH

Feb 5, 2026

Fresenius Kabi Compounding Recalls Ketamine Injection for Sterility Risk

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Fresenius Kabi Compounding

Lack of

HIGH

Feb 5, 2026

Fresenius Kabi Compounding Recalls Thiamine Injection Over Sterility Risk

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Fresenius Kabi Compounding

Lack of

HIGH

Feb 2, 2026

Pro Numb Tattoo Numbing Spray Recalled Due to cGMP Violations

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PRO NUMB SENSITIVE SKIN

cGMP deviations

HIGH

Feb 2, 2026

Pro Numb Tattoo Numbing Spray Recalled Due to cGMP Deviations

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PRO NUMB

cGMP deviations