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

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

How can I find out if my EDAN Patient Monitor is affected?

Check the model number and serial numbers against the recalled lists provided by Edan Diagnostics.

What are the risks associated with using the EDAN Patient Monitor?

The risks include potential cybersecurity vulnerabilities that could affect patient monitoring and care.

Is there a refund available for returned devices?

Contact Edan Diagnostics or your healthcare provider for details on refunds and the return process.

Where can I find more information about the recall?

Visit the FDA's official recall notice for detailed information and updates regarding the EDAN Patient Monitor recall.

How long will it take to process a refund?

Typically, refunds can take 4-6 weeks to process after the return is received.

What if my healthcare provider is unresponsive about the recall?

If your healthcare provider does not respond, you can contact Edan Diagnostics directly for assistance.

Do I need to keep the device as evidence?

Yes, it is advisable to keep the device until you have completed the return process to document the recall.

Will I receive a notification about the recall?

Yes, notifications are being sent out by Edan Diagnostics to all affected parties.

What kind of monitoring does the EDAN Patient Monitor perform?

The EDAN Patient Monitor performs continuous monitoring of multiple physiological parameters, assisting healthcare providers in evaluating patient conditions.

HIGHOctober 24, 2025

EDAN Patient Monitors Recalled Over Cybersecurity Issues

EDAN recalled 3,824 Patient Monitors on October 24, 2025. The recall follows an FDA letter regarding cybersecurity vulnerabilities. Affected models include X8, X10, and X12, distributed nationwide and to 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 EDAN Patient Monitors X8, X10, and X12. They were sold worldwide, including in California, Kentucky, Puerto Rico, Florida, Connecticut, Illinois, Pennsylvania, Rhode Island, North Carolina, New York, Louisiana, Texas, and Michigan, as well as Mexico. The devices have been used for continuous monitoring of multiple physiological parameters.

The Hazard

The recall stems from potential cybersecurity issues that may compromise the functionality of the devices. This poses a high risk, as it could affect the monitoring of patients' vital signs, leading to inadequate medical response in emergencies.

Reported Incidents

No reported injuries or deaths have been linked to the cybersecurity vulnerabilities at this time. However, the risk level is classified as high due to the potential for serious consequences if the devices are not secured.

What to Do

Stop using the affected Patient Monitors immediately. Follow the manufacturer's recall instructions and contact Edan Diagnostics or your healthcare provider for further guidance.

Contact Information

For more information, contact Edan Diagnostics at their customer service line or visit their website. More details are available through the FDA's recall notice.

Key Facts

Recalled models: X8, X10, X12
Quantity: 3,824 units
High risk due to cybersecurity vulnerabilities
Immediate stop-use advised

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 TypePatient Monitor

Product Details

Brand

Edan Diagnostics

Categories

Health & Personal Care Medical Devices

Model Numbers

EDAN Model: X8 UDI-DI code: 06944413810907 Serial/Lot Numbers: 261586-M21116620010 261586-M21116620002 261586-M21116620007 261586-M21116620006 261586-M21116620009 261586-M21116630001 261586-M21116620008 261586-M21116620003 261586-M21116630005 261586-M21116630003 261586-M21116620004 261586-M21116620001 261586-M21116630004 261586-M21116630002 261586-M21116620005 261586-M21301970003 261586-M21301970004 261586-M21301960001 261586-M21301970005 261586-M21301960003 261586-M21301970002 261586-M21301970001 261586-M21301960002 261586-M21714500002 261586-M21714500001 261586-M21714500003 261586-M21816750005 261586-M21816750003 261586-M21816750002 261586-M21816750004 261586-M21816750001 261586-M22105750001 261586-M22105750007 261586-M22105750008 261586-M22105750010 261586-M22105750002 261586-M22105750005 261586-M22105750009 261586-M22105750006 261586-M22105750003 261586-M22105750004 261586-M22405430007 261586-M22405430001 261586-M22405430004 261586-M22405430010 261586-M22405430006 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261586-M24C02200001 261586-M24C02200006 EDAN Model: X10 UDI-DI code: 06944413810921 Serial/Lot Numbers: 261590-M21116650004 261590-M21116640010 261590-M21116650001 261590-M21116640009 261590-M21116640002 261590-M21116640001 261590-M21116640008 261590-M21116640006 261590-M21116650003 261590-M21116640004 261590-M21116650005 261590-M21116640007 261590-M21116640003 261590-M21116640005 261590-M21116650002 261590-M21301930004 261590-M21301930003 261590-M21301930002 261590-M21301940001 261590-M21301940003 261590-M21301930005 261590-M21301930001 261590-M21301940002 261590-M21608900002 261590-M21608900001 261590-M21608900003 261590-M21608900004 261590-M21714510002 261590-M21714510005 261590-M21714510001 261590-M21714510003 261590-M21714510004 261590-M21816760004 261590-M21816760003 261590-M21816760005 261590-M21816760002 261590-M21816760001 261590-M21C04540001 261590-M21C04540005 261590-M21C04540009 261590-M21C04540003 261590-M21C04540004 261590-M21C04540007 261590-M21C04540015 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261590-M22B07360019 261590-M22B07360021 261590-M22B07360013 261590-M22B07360014 261590-M22B07360016 261590-M22B07360031 261590-M22B07360047 261590-M22B07360048 261590-M22B07360037 261590-M22B07360025 261590-M23222350007 261590-M23222350017 261590-M23222350023 261590-M23222350035 261590-M23222350029 261590-M23222350028 261590-M23222350019 261590-M23222350018 261590-M23222350009 261590-M23222350008 261590-M23222350014 261590-M23222350032 261590-M23222350031 261590-M23222350030 261590-M23222350004 261590-M23222350025 261590-M23222350033 261590-M23222350026 261590-M23222350024 261590-M23222350016 261590-M23222350039 261590-M23222350038 261590-M23222350015 261590-M23222350005 261590-M23222350037 261590-M23222350022 261590-M23222350021 261590-M23222350020 261590-M23222350040 261590-M23222350012 261590-M23222350011 261590-M23222350010 261590-M23222350002 261590-M23222350001 261590-M23222350036 261590-M23222350034 261590-M23222350027 261590-M23222350013 261590-M23222350006 261590-M23222350003 261590-M23614470039 261590-M23614470033 261590-M23614470024 261590-M23614470021 261590-M23614470019 261590-M23614470002 261590-M23614470011 261590-M23614470034 261590-M23614470031 261590-M23614470029 261590-M23614470023 261590-M23614470018 261590-M23614470017 261590-M23614470014 261590-M23614470035 261590-M23614470015 261590-M23614470005 261590-M23614470001 261590-M23614470003 261590-M23614470022 261590-M23614470016 261590-M23614470010 261590-M23614470009 261590-M23614470030 261590-M23614470036 261590-M23614470037 261590-M23614470028 261590-M23614470027 261590-M23614470026 261590-M23614470020 261590-M23614470013 261590-M23614470007 261590-M23614470006 261590-M23614470012 261590-M23614470040 261590-M23614470038 261590-M23614470032 261590-M23614470008 261590-M23614470004 261590-M23614470025 261590-M23818720033 261590-M23818720029 261590-M23818720003 261590-M23818720005 261590-M23818720011 261590-M23818720038 261590-M23818720030 261590-M23818720028 261590-M23818720024 261590-M23818720019 261590-M23818720017 261590-M23818720006 261590-M23818720034 261590-M23818720009 261590-M23818720016 261590-M23818720022 261590-M23818720027 261590-M23818720035 261590-M23818720032 261590-M23818720021 261590-M23818720040 261590-M23818720039 261590-M23818720037 261590-M23818720025 261590-M23818720018 261590-M23818720014 261590-M23818720031 261590-M23818720026 261590-M23818720010 261590-M23818720007 261590-M23818720002 261590-M23818720036 261590-M23818720023 261590-M23818720015 261590-M23818720012 261590-M23818720013 261590-M23818720001 261590-M23818720020 261590-M23818720008 261590-M23818720004 261590-M23911440017 261590-M2391

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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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

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Feb 5, 2026

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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