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

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

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-1144-2026
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
136
Distribution
Nationwide
Made in
United States
Lot / code info
EDAN Model: iM3s UDI-DI code: 06944413811171 Serial/Lot Numbers: 262825-H24701480005 262825-H24701480001 262825-H24701480002 262825-H24701480007 262825-H24701480010 262825-H24701480009 262825-H24701480008 262825-H24701480004 262825-H24701480003 262825-H24701480006 262825-H24802410006 262825-H24802410003 262825-H24802410007 262825-H24802410009 262825-H24802410010 262825-H24802410002 262825-H24802410005 262825-H24802410001 262825-H24802410008 262825-H24802410004 261573-M21708880001 261573-M21803610001 261573-M21C04280007 261573-M21C04280003 261573-M21C04280004 261573-M21C04280008 261573-M21C04280002 261573-M21C04280012 261573-M21C04280011 261573-M21C04280010 261573-M21C04280009 261573-M21C04280006 261573-M21C04280013 261573-M21C04280001 261573-M21C04280014 261573-M21C04280005 261573-M21C04280015 261573-M22701100009 261573-M22701100014 261573-M22701100019 261573-M22701100022 261573-M22701100025 261573-M22701100004 261573-M22701100021 261573-M22701100018 261573-M22701100008 261573-M22701100001 261573-M22701100020 261573-M22701100012 261573-M22701100005 261573-M22701100002 261573-M22701100011 261573-M22701100024 261573-M22701100013 261573-M22701100015 261573-M22701100023 261573-M22701100017 261573-M22701100007 261573-M22701100016 261573-M22701100006 261573-M22701100010 261573-M22701100003 262825-M23810180001 262825-M23810180002 261572-M20101720006 263089-H24503150005 263089-H24503150003 263089-H24503150006 263089-H24503150001 263089-H24503150010 263089-H24503150002 263089-H24503150014 263089-H24503150008 263089-H24503150009 263089-H24503150013 263089-H24503150012 263089-H24503150007 263089-H24503150011 263089-H24503150004 263089-H24503150015 262825-H25300480002 262825-H25300480001 263163-H25401870003 263163-H25401870004 263089-H25502070002 263089-H25502070016 263163-H25401870007 263163-H25401870008 263163-H25401870005 263163-H25401870001 263163-H25401870002 263163-H25401870006 263163-H25401870010 262825-H25502470009 263089-H25502070008 263089-H25502070012 263089-H25502070015 263089-H25502070013 263089-H25502070006 263089-H25502070011 263089-H25502070017 263089-H25502070019 263089-H25502070004 263163-H25401870009 263089-H25502070010 263089-H25502070009 263089-H25502070007 263089-H25502070001 263089-H25502070018 263089-H25502070005 263089-H25502070003 262825-H25502470003 262825-H25502470002 262825-H25502470008 262825-H25502470001 262825-H25502470005 262825-H25502470006 262825-H25502470007 263089-H25502070014 262825-H25502470004 262825-H25502470010 263089-H25701330006 263089-H25701330008 263089-H25701330013 263089-H25701330004 263089-H25701330012 263089-H25701330014 263089-H25701330002 263089-H25701330015 263089-H25701330010 263089-H25701330007 263089-H25701330003 263089-H25701330001 263089-H25701330009 263089-H25701330011 263089-H25701330005
UPC codes
06944413811171

Products covered by this recall

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital signs monitors including iM3s/iM3As/iM3Bs/iHM3s are intended to be used for measuring, storing, reviewing of, and generating prompts for multiple physiological parameters of adults and pediatrics. Component: No

Check your product

The notice names 5 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.

  • 06944413811171

Lot or batch code

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

  • 262825-H24701480005 262825-H24701480001 262825-H24701480002 2628

Model or item number

On the rating label, the box or the instruction sheet.

  • iM3s
  • iM3As
  • iM3Bs

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 — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  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.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

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 06944413811171; lot code 262825-H24701480005 262825-H24701480001 262825-H24701480002 2628; model number iM3s, iM3As, iM3Bs. 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?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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