What should I do if I own a recalled EDAN patient monitor?

Stop using the device immediately and contact Edan Diagnostics for return instructions.

How can I check if my EDAN patient monitor is affected?

Verify the model number and serial numbers against the recall notice on the FDA website.

What are the risks associated with using an affected monitor?

The monitor may have cybersecurity vulnerabilities that could compromise patient data and safety.

Will I receive a refund for the recalled monitor?

Yes, follow the return instructions provided by the manufacturer to receive a refund.

Where can I find more information about the recall?

Visit the FDA recall notice page for detailed information regarding the recall and next steps.

Are there any injuries related to this recall?

No injuries or deaths have been reported in connection with this recall.

What models are included in the recall?

The recall includes the iM8, iM8A, and iM8B models of the EDAN Patient Monitor.

How do I contact Edan Diagnostics?

You can contact Edan Diagnostics through their customer service number, which is provided on their official website.

What is the deadline for returning the recalled monitors?

Follow the manufacturer's instructions for the return process, as there may be specific deadlines.

What makes these monitors a high-risk recall?

The potential cybersecurity issues pose a significant risk to patient data and device functionality.

HIGHOctober 24, 2025

EDAN Recalls Patient Monitors Due to Cybersecurity Risks

EDAN recalled 3,141 patient monitors on October 24, 2025, due to potential cybersecurity vulnerabilities. The recall affects models iM8, iM8A, and iM8B used for monitoring physiological parameters. Healthcare providers must stop using these devices immediately and follow the manufacturer's 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 the EDAN Patient Monitor models iM8, iM8A, and iM8B. These monitors were distributed worldwide, including in California, Kentucky, and Mexico, and are used for continuous monitoring of vital signs. No price information is provided.

The Hazard

The recall is due to potential cybersecurity issues that may compromise patient data and device functionality. Such vulnerabilities can lead to serious risks in a healthcare setting, impacting patient safety.

Reported Incidents

No injuries or deaths have been reported associated with this recall. However, the potential for data breaches poses significant risks in medical environments.

What to Do

Stop using the affected patient monitors immediately. Contact Edan Diagnostics or your healthcare provider for specific instructions on returning the devices.

Contact Information

For more information, contact Edan Diagnostics at their customer service number or visit their official website. Details can also be found on the FDA recall notice page.

Key Facts

3141 units recalled
Models affected: iM8, iM8A, iM8B
Potential cybersecurity risks
Stop use immediately and follow manufacturer instructions

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: iM8 UDI-DI code: 06944413801592 Serial/Lot Numbers: 260645-M15C07240016 260645-M15C07240001 260645-M15C07240004 260645-M15C07240005 260645-M15C07240017 260645-M15C07240006 260645-M15C07240007 260645-M15C07240008 260645-M15C07240015 260645-M15C07240009 260645-M15C07240018 260645-M15C07240019 260645-M15C07240020 260645-M15C07240010 260645-M15C07240011 260645-M15C07240012 260645-M15C07240013 260645-M15C07240014 260645-M15C07240002 260645-M15C07240003 260645-M16200530008 260645-M16200530007 260645-M16200530006 260645-M16200530005 260645-M16200530001 260645-M16200530003 260645-M16200530002 260645-M16200530004 260605-M16304610008 260605-M16304610010 260605-M16304610007 260605-M16304610009 260605-M16304610006 260605-M16304610001 260605-M16304610004 260605-M16304610003 260605-M16304610002 260605-M16304610005 260605-K16300150005 260605-K16300150006 260605-K16300150007 260605-K16300150008 260605-K16300150009 260605-K16300150010 260605-K16300150004 260645-M16203940001 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260605-M20808580030 260605-M20808580034 260605-M20808580002 260605-M20808580027 260605-M20808580010 260605-M20808580016 260605-M20808580058 260605-M20808580035 260605-M20808580051 260605-M20808580055 260605-M20808580007 260605-M20808580037 260605-M20808580041 260605-M20808580045 260605-M20808580047 260605-M20808580008 260605-M20808580014 260605-M20808580019 260605-M20808580038 260605-M20808580046 260605-M20808580048 260605-M20808580003 260605-M20808580009 260605-M20808580018 260605-M20808580057 260605-M20808580031 260605-M20808580060 260605-M20808580028 260605-M20808580013 260605-M20808580026 260605-M20808580

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