Class II U.S. Food and Drug Administration

Brand Name: EDAN Product Name: Fetal 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-1140-2026
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
3721
Distribution
Nationwide
Made in
United States
Lot / code info
EDAN Model: F3 UDI-DI code: 06944413800847 Serial/Lot Code: 460085-M16105760001 460085-M16105760002 460085-M16105760003 460085-M16105760004 460085-M16105760005 460085-M16105760006 460085-M16105760007 460085-M16105760008 460085-M16105760009 460085-M16105760010 460085-M16105760011 460085-M16105760012 460085-M16105760013 460085-M16105760014 460085-M16105760015 460085-M16105760016 460085-M16105760017 460085-M16105760018 460085-M16105760019 460085-M16105760020 460085-M16105760021 460085-M16105760022 460085-M16105760023 460085-M16105760024 460085-M16105760025 460085-M16105760026 460085-M16105760027 460085-M16105760028 460085-M16105760029 460085-M16105760030 460085-M16105760031 460085-M16105760032 460085-M16105760033 460085-M16105760034 460085-M16105760035 460085-M16105760036 460085-M16105760037 460085-M16105760038 460085-M16105760039 460085-M16105760040 460085-M16105760041 460085-M16105760042 460085-M16105760043 460085-M16105760044 460085-M16105760045 460085-M16105760046 460085-M16105760047 460085-M16105760048 460085-M16105760049 460085-M16105760050 460085-M16105760051 460085-M16105760052 460085-M16105760053 460085-M16803010001 460085-M16803010002 460085-M16803010003 460085-M16803010004 460085-M16803010005 460085-M16803010006 460085-M16803010007 460085-M16803010008 460085-M16803010009 460085-M16803010010 460085-M16803010011 460085-M16803010012 460085-M16803010013 460085-M16803010014 460085-M16803010015 460085-M16803010016 460085-M16803010017 460085-M16803010018 460085-M16803010019 460085-M16803010020 460085-M16803010021 460085-M16803010022 460085-M16803010023 460085-M16803010024 460085-M16803010025 460085-M16803010026 460085-M16803010027 460085-M16803010028 460085-M16803010029 460085-M16803010030 460085-M16803010031 460085-M16803010032 460085-M16803010033 460085-M16803010034 460085-M16803010035 460085-M16803010036 460085-M16803010037 460085-M16803010038 460085-M16803010039 460085-M16803010040 460085-M16803010041 460085-M16803010042 460085-M16803010043 460085-M16803010044 460085-M16803010045 460085-M16803010046 460085-M16803010047 460085-M16803010048 460085-M16803010049 460085-M16803010050 460085-M16803010051 460085-M16803010052 460085-M16803010053 460085-M16803010054 460085-M16803010055 460085-M16803010056 460085-M16803010057 460085-M16803010058 460085-M16803010059 460085-M16803010060 460085-M16803010061 460085-M16803010062 460085-M16803010063 460085-M16803010064 460085-M16A04870001 460085-M16A04870002 460085-M16A04870003 460085-M16A04870004 460085-M16A04870005 460085-M16A04870006 460085-M16A04870007 460085-M16A04870008 460085-M16A04870009 460085-M16A04870010 460085-M16A04870011 460085-M16A04870012 460085-M16A04870013 460085-M16A04870014 460085-M16A04870015 460085-M16A04870016 460085-M16A04870017 460085-M16A04870018 460085-M16A04870019 460085-M16A04870020 460085-M16A04870021 460085-M16A04870022 460085-M16A04870023 460085-M16A04870024 460085-M16A04870025 460085-M16A04870026 460085-M16A04870027 460085-M16A04870028 460085-M16A04870029 460085-M16A04870030 460085-M16A04870031 460085-M16A04870032 460085-M16A04870033 460085-M16A04870034 460085-M16A04870035 460085-M16A04870036 460085-M16A04870037 460085-M16A04870038 460085-M16A04870039 460085-M16A04870040 460085-M16A04870041 460085-M16A04870042 460085-M16A04870043 460085-M16A04870044 460085-M16A04870045 460085-M16A04870046 460085-M16A04880001 460085-M16A04880002 460085-M16A04880003 460085-M16A04880004 460085-M16A04880005 460085-M16A04880006 460085-M16A04880007 460085-M16A04880008 460085-M16A04880009 460085-M16A04880010 460085-M16A04880011 460085-M16A04880012 460085-M16A04880013 460085-M16A04880014 460085-M16A04880015 460085-M16A04880016 460085-M16A04880017 460085-M16A04880018 460085-M16A04880019 460085-M16A04880020 460085-M16A04880021 460085-M16A04880022 460085-M16A04880023 460085-M16A04880024 460085-M16A04880025 460085-M16A04880026 460085-M16A04880027 460085-M16A04880028 460085-M16A04880029 460085-M16A04880030 460085-M16A04880031 460085-M16A04880032 460085-M16A04880033 460085-M16A04880034…
UPC codes
06944413800847

Products covered by this recall

Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. Component: No

Check your product

The notice names 3 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.

  • 06944413800847

Lot or batch code

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

  • 460085-M16105760001 460085-M16105760002 460085-M16105760003 4600

Model or item number

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

  • F2

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. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

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 06944413800847; lot code 460085-M16105760001 460085-M16105760002 460085-M16105760003 4600; model number F2. 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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