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-1153-2026
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
12201
Distribution
Nationwide
Made in
United States
Lot / code info
EDAN Model: M3A UDI-DI code: 06944413800786 Serial/Lot Numbers: 260760-M16406920062 260760-M16406920035 260760-M16406920036 260760-M16406920037 260760-M16406920038 260760-M16406920039 260760-M16406920040 260760-M16406920041 260760-M16406920042 260760-M16406920043 260760-M16406920044 260760-M16406920045 260760-M16406920046 260760-M16406920047 260760-M16406920048 260760-M16406920049 260760-M16406920050 260760-M16406920051 260760-M16406920052 260760-M16406920053 260760-M16406920054 260760-M16406920055 260760-M16406920056 260760-M16406920057 260760-M16406920058 260760-M16406920059 260760-M16406920060 260760-M16406920061 260760-M16406920034 260760-M16406920033 260760-M16406920001 260760-M16406920031 260760-M16406920063 260760-M16406920002 260760-M16406920003 260760-M16406920004 260760-M16406920005 260760-M16406920006 260760-M16406920007 260760-M16406920008 260760-M16406920009 260760-M16406920010 260760-M16406920011 260760-M16406920012 260760-M16406920013 260760-M16406920014 260760-M16406920015 260760-M16406920016 260760-M16406920017 260760-M16406920019 260760-M16406920020 260760-M16406920021 260760-M16406920022 260760-M16406920023 260760-M16406920024 260760-M16406920025 260760-M16406920026 260760-M16406920027 260760-M16406920028 260760-M16406920029 260760-M16406920030 260760-M16406920032 260760-M16406920064 260760-M16406920018 260760-M16406920066 260760-M16406920065 260760-M16406920070 260760-M16406920069 260760-M16406920068 260760-M16406920067 260084-M16408640030 260084-M16408640029 260084-M16408640028 260084-M16408640004 260084-M16408640026 260084-M16408640027 260084-M16408640023 260084-M16408640022 260084-M16408640021 260084-M16408640020 260084-M16408640019 260084-M16408640018 260084-M16408640017 260084-M16408640016 260084-M16408640015 260084-M16408640014 260084-M16408640012 260084-M16408640013 260084-M16408640010 260084-M16408640025 260084-M16408640024 260084-M16408640001 260084-M16408640011 260084-M16408640003 260084-M16408640002 260084-M16408640006 260084-M16408640007 260084-M16408640008 260084-M16408640009 260084-M16408640005 260760-M16604770010 260760-M16604770009 260760-M16604770008 260760-M16604770007 260760-M16604770006 260760-M16604770005 260760-M16604770002 260760-M16604770003 260760-M16604770001 260760-M16604770011 260760-M16604770004 260760-M16604770012 260760-M16604770014 260760-M16604770015 260760-M16604770016 260760-M16604770017 260760-M16604770018 260760-M16604770019 260760-M16604770020 260760-M16604770013 260760-M16604780026 260760-M16604780021 260760-M16604780022 260760-M16604780023 260760-M16604780024 260760-M16604780025 260760-M16604780027 260760-M16604780033 260760-M16604780029 260760-M16604780030 260760-M16604780031 260760-M16604780032 260760-M16604780020 260760-M16604780034 260760-M16604780035 260760-M16604780028 260760-M16604780019 260760-M16604780013 260760-M16604780017 260760-M16604780001 260760-M16604780002 260760-M16604780003 260760-M16604780004 260760-M16604780005 260760-M16604780036 260760-M16604780007 260760-M16604780008 260760-M16604780009 260760-M16604780010 260760-M16604780011 260760-M16604780012 260760-M16604780014 260760-M16604780015 260760-M16604780016 260760-M16604780018 260760-M16604780006 260760-M16604780037 260760-M16604780039 260760-M16604780063 260760-M16604780064 260760-M16604780065 260760-M16604780066 260760-M16604780067 260760-M16604780068 260760-M16604780038 260760-M16604780070 260760-M16604780061 260760-M16604780071 260760-M16604780073 260760-M16604780074 260760-M16604780075 260760-M16604780076 260760-M16604780077 260760-M16604780078 260760-M16604780079 260760-M16604780080 260760-M16604780072 260760-M16604780060 260760-M16604780069 260760-M16604780058 260760-M16604780040 260760-M16604780041 260760-M16604780042 260760-M16604780043 260760-M16604780044 260760-M16604780045 260760-M16604780059 260760-M16604780047 260760-M16604780048 260760-M16604780046 260760-M16604780050 260760-M16604780049 260760-M16604780056 260760-M16604780055 260760-M16604780054 260760-M16604780053 260760-M1660478…
UPC codes
06944413800786

Products covered by this recall

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-invasive blood pressure (NIBP), the oxygen saturation of the blood (SpO2) and Rectal/Oral/Auxiliary/Ear temperature measurement. 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.

  • 06944413800786

Lot or batch code

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

  • 260760-M16406920062 260760-M16406920035 260760-M16406920036 2607

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 you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

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 06944413800786; lot code 260760-M16406920062 260760-M16406920035 260760-M16406920036 2607. 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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