Class II U.S. Food and Drug Administration

Brand Name: EDAN Product Name: Vital Signs Monitor Model/ recall: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA

Recall published 9 months ago

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.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1143-2026
Published
January 28, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Edan Diagnostics
Product type
Medical devices
Units affected
11987
Distribution
Nationwide
Made in
United States
Lot / code info
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 261436-M20707940007 261436-M20707940015 261436-M20707940017 261436-M20707940019 261436-M20808640010 261436-M20808640006 261436-M20808640008 261436-M20808640003 261436-M20808640005 261436-M20808640009 261436-M20808640001 261436-M20808640002 261436-M20808640007 261436-M20808640004 261436-M20914760002 261436-M20914760025 261436-M20914760015 261436-M20914760024 261436-M20914760023 261436-M20914760020 261436-M20914760016 261436-M20914760014 261436-M20914760013 261436-M20914760001 261436-M20914760012 261436-M20914760011 261436-M20914760010 261436-M20914760007 261436-M20914760018 261436-M20914760017 261436-M20914760008 261436-M20914760006 261436-M20914760004 261436-M20914760003 261436-M20914760009 261436-M20914760005 261436-M20914760022 261436-M20914760021 261436-M20914760019 261478-M18208600001 261436-M20B13260015 261436-M20B13260048 261436-M20B13260044 261436-M20B13260035 261436-M20B13260049 261436-M20B13260046 261436-M20B13260042 261436-M20B13260028 261436-M20B13260025 261436-M20B13260022 261436-M20B13260012 261436-M20B13260029 261436-M20B13260043 261436-M20B13260047 261436-M20B13260005 261436-M20B13260016 261436-M20B13260017 261436-M20B13260019 261436-M20B13260031 261436-M20B13260033 261436-M20B13260024 261436-M20B13260026 261436-M20B13260001 261436-M20B13260018 261436-M20B13260040 261436-M20B13260007 261436-M20B13260011 261436-M20B13260013 261436-M20B13260030 261436-M20B13260002 261436-M20B13260006 261436-M20B13260009 261436-M20B13260010 261436-M20B13260045 261436-M20B13260050 261436-M20B13260004 261436-M20B13260008 261436-M20B13260014 261436-M20B13260020 261436-M20B13260021 261436-M20B13260032 261436-M20B13260036 261436-M20B13260037 261436-M20B13260039 261436-M20B13260023 261436-M20B13260027 261436-M20B13260034 261436-M20B13260038 261436-M20B13260041 261436-M20B13260003 261436-M20B15440003 261436-M20C15770021 261436-M20C15770016 261436-M20C15770008 261436-M20C15770007 261436-M20B20350081 261436-M20B20350077 261436-M20B20350068 261436-M20B20350058 261436-M20B20350052 261436-M20B20350046 261436-M20B20350041 261436-M20B20350037 261436-M20B20350033 261436-M20B20350030 261436-M20B20350028 261436-M20B20350022 261436-M20B20350006 261436-M20C13740012 261436-M20C13740010 261436-M20C13740002 261436-M20B15440004 261436-M20B15440005 261436-M20B15440016 261436-M20B15440020 261436-M20B15440018 261436-M20B15440010 261436-M20B15440006 261436-M20C15770025 261436-M20C15770019 261436-M20C15770001 261436-M20B20350084 261436-M20B20350061 261436-M20B20350056 261436-M20B20350051 261436-M20B15440021 261436-M20B20350048 261436-M20B20350036 261436-M20B20350029 261436-M20B20350008 261436-M20B20350002 261436-M20C13740009 261436-M20C13740004 261436-M20C13740011 261436-M20C13740008 261436-M20C13740001 261436-M20B20350042 261436-M20B15440017 261436-M20B15440009 261436-M20B15440008 261436-M20B15440019 261436-M20C15770023 261436-M20C15770018 261436-M20C15770017 261436-M20C15770010 261436-M20C15770006 261436-M20B20350089 261436-M20B20350067 261436-M20B20350063 261436-M20B20350060 261436-M20B2035…
UPC codes
06944413808812

Products covered by this recall

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), and Quick TEMP/Infrared TEMP (TEMP). iM3 capabilities include storing, displaying measuring data. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. Component: No

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 06944413808812

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 261436-M19B06650005 261436-M19B06650003 261436-M19B06660007 2614

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Edan Diagnostics — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Edan Diagnostics — 9833 Pacific Heights Blvd, San Diego, CA, 92121-4707

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Edan Diagnostics medical devices recalled?

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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 06944413808812; lot code 261436-M19B06650005 261436-M19B06650003 261436-M19B06660007 2614. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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