Is my EDAN iT20 telemetry transmitter affected by the recall?

Check the model number and serial numbers listed in the recall notice. If your device matches, it is affected.

What should I do if I used the device?

Stop using the device immediately and contact your healthcare provider for advice. Follow the recall instructions provided.

How do I obtain a refund or replacement?

Contact EDAN Diagnostics for specific instructions on how to return the device and request a refund or replacement.

What are the risks associated with using the recalled device?

Potential cybersecurity issues could lead to unauthorized access to sensitive patient data, posing risks to privacy and safety.

How will I be notified about the recall?

Notifications are being sent through letters to affected users, providing details and instructions regarding the recall.

Can I still use the device while waiting for instructions?

No, do not use the device until you receive specific instructions from EDAN Diagnostics.

What if I can't find my serial number?

Contact EDAN Diagnostics for assistance. They can help you determine if your device is affected based on your purchase details.

Is there a deadline to return the device?

While specific deadlines may not be stated, it's advisable to act quickly and follow the instructions as soon as possible.

What happens if I ignore the recall?

Ignoring the recall may expose you to cybersecurity risks and potential misuse of your health data.

Will I receive compensation for the returned device?

Yes, you should receive a refund or replacement as specified in the recall instructions.

HIGHOctober 24, 2025

EDAN Telemetry Transmitter Recalled Over Cybersecurity Concerns

EDAN recalled 1,457 iT20 telemetry transmitters on October 24, 2025, due to potential cybersecurity issues. The recall affects devices distributed in the United States and Mexico. Healthcare providers and patients must immediately discontinue use of the device.

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 telemetry transmitter, model iT20. This device collects physiological parameters including ECG and SpO2 through sensors. It was distributed worldwide, including states like CA, KY, and TX.

The Hazard

The recall stems from an FDA It Has Come to Our Attention Letter regarding potential cybersecurity vulnerabilities. These issues could compromise patient data and device functionality.

Reported Incidents

No injuries or incidents have been reported related to this recall. However, the potential for cybersecurity threats poses a significant risk to users.

What to Do

Stop using the telemetry transmitter immediately. Contact EDAN Diagnostics or your healthcare provider for further instructions. Follow the recall instructions provided in the notification letter.

Contact Information

For more information, contact EDAN Diagnostics at 1-800-XXX-XXXX or visit their website. Additional details are available on the FDA's recall page.

Key Facts

Recall date: October 24, 2025
Quantity recalled: 1,457 units
Affected states: CA, KY, TX, and others
Contact EDAN for further 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 TypeTelemetry Transmitter

Product Details

Brand

Edan Diagnostics

Categories

Health & Personal Care Medical Devices

Model Numbers

EDAN Model: iT20 UDI-DI code: 06944413802261 Serial/Lot Numbers: 261350-M17A03030002 261350-M17A03030001 260881-M18407300001 260881-M18407300002 260881-M18407310002 260881-M18407310001 260881-M18703320002 260881-M18703320004 260881-M18703320001 260881-M18703320003 260881-M18800890008 260881-M18800890003 260881-M18800890004 260881-M18800890005 260881-M18800890007 260881-M18800890001 260881-M18800890006 260881-M18800890002 260881-M18800890010 260881-M18810400010 260881-M18810400009 260881-M18810400008 260881-M18810400004 260881-M18810400003 260881-M18810410008 260881-M18810410006 260881-M18810410002 260881-M18810400007 260881-M18810400002 260881-M18810400001 260881-M18810410003 260881-M18810410007 260881-M18810410001 260881-M18810410010 260881-M18810410005 260881-M18810410009 260881-M18810410004 260881-M18810400005 260881-M18810400006 260881-M18901010006 260881-M18901000007 260881-M18901000009 260881-M18901000012 260881-M18901000017 260881-M18901000018 260881-M18901000002 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262651-M25922630004 262651-M25922630027 262651-M25922630016 262651-M25922630010 262651-M25922630009 262651-M25922630023 262651-M25922630018 262651-M25922630012 262651-M25922630014 262651-M25922630017 262651-M25922630021

Affected States

ALL

Report Date

January 28, 2026

Source Agency

FDA - Medical Devices

Recall Status

ACTIVE

Related Recalls

MEDIUM

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CETRORELIX ACETATE

Defective delivery

HIGH

Feb 5, 2026

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Fresenius Kabi Compounding

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

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