Class II U.S. Food and Drug Administration

Brand Name: EDAN Product Name: Fetal & Maternal 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

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

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-1141-2026
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
3518
Distribution
Nationwide
Made in
United States
Lot / code info
EDAN Model: F9 UDI-DI code: 06944413800434 Serial/Lot Numbers: 460430-M16105660001 460430-M16700280001 460475-M16605590001 460475-M16605590002 460475-M16605590003 460475-M16605590004 460475-M16806530001 460475-M16806530002 460476-M16B07550001 460476-M16B07550002 460476-M16B07550003 460476-M17402630001 460476-M17402630002 460476-M17402630003 460476-M17402630004 460476-M17402630005 460476-M17607650001 460476-M17607650002 460476-M17607650003 460476-M17607650004 460476-M17607650005 460476-M17607650006 460476-M17607650007 460476-M17607650008 460476-M17607650009 460476-M17607650010 460517-M16804200001 460688-M17A07770001 460688-M17A07770002 460688-M17A07770003 460723-M17904190001 460945-M18200660001 460945-M18200660002 460945-M18200660003 460945-M18200660004 460945-M18200660005 460945-M18200660006 460945-M18200660007 460945-M18200660008 460945-M18200660009 460945-M18200660010 460945-M18200660011 460945-M18200660012 460945-M18200660013 460945-M18200660014 460945-M18200660015 460945-M18200660016 460945-M18200660017 460945-M18200660018 460945-M18200660019 460945-M18200660020 460945-M18200660021 460945-M18200660022 460945-M18200660023 460945-M18200660024 460945-M18200660025 460945-M18200660026 460945-M18200660027 460945-M18200660028 460945-M18200660029 460945-M18200660030 460945-M18200660031 460945-M18200660032 460956-M18504390001 460956-M18504390002 460956-M18504390003 460956-M18504390004 460956-M18504390005 460956-M18504390006 460956-M18504390007 460956-M18504390008 460956-M18504390009 460956-M18504390010 460956-M18504390011 460956-M18504390012 460956-M18504390013 460956-M18504390014 460956-M18504390015 460956-M18504390016 460956-M18504390017 460956-M18504390018 460956-M18504390019 460956-M18504390020 460956-M18504390021 460956-M18504390022 460956-M18504390023 460956-M18504390024 460956-M18504390025 460956-M18504390026 460956-M18504390027 460956-M18504390028 460956-M18504390029 460956-M18504390030 460956-M18504390031 460956-M18504390032 460956-M18700640001 460956-M18700640002 460956-M18700640003 460956-M18700640004 460956-M18700640005 460956-M18700640006 460956-M18700640007 460956-M18700640008 460956-M18700640009 460956-M18700640010 460956-M18700640011 460956-M18700640012 460956-M18700640013 460956-M18700640014 460956-M18700640015 460956-M18700640016 460956-M18700640017 460956-M18700640018 460956-M18700640019 460956-M18700640020 460956-M18803860001 460956-M18803860002 460956-M18803860003 460956-M18803860004 460956-M18803860005 460956-M18803860006 460956-M18803860007 460956-M18803860008 460956-M18B00450001 460956-M18B00450002 460956-M18B00450003 460956-M18B00450004 460956-M18B00450005 460956-M18B00450006 460956-M18B00450007 460956-M18B00450008 460956-M18B00450009 460956-M18B00450010 460956-M18B00450011 460956-M18B00450012 460956-M18B00450013 460956-M18B00450014 460956-M18B00450015 460956-M18B00450016 460956-M18B00450017 460956-M18B00450018 460956-M18B00450019 460956-M18B00450020 460956-M18B00450021 460956-M18B00450022 460956-M18B00450023 460956-M18B00450024 460956-M18B00450025 460956-M18B00450026 460956-M18B00450027 460956-M18B00450028 460956-M18B00450029 460956-M18B00450030 460956-M18B00450031 460956-M18B00450032 460956-M18B00450033 460956-M18B00450034 460956-M18B00450035 460956-M18B00450036 460956-M19312930001 460956-M19312930002 460956-M19312930003 460956-M19312930004 460956-M19312930005 460956-M19312930006 460956-M19312930007 460956-M19312930008 460956-M19312930009 460956-M19312930010 460956-M19312930011 460956-M19312930012 460956-M19312930013 460956-M19312930014 460956-M19312930015 460956-M19312930016 460956-M19312930017 460956-M19312930018 460956-M19312930019 460956-M19312930020 460956-M19703230001 460956-M19703230002 460956-M19703230003 460956-M19703230004 460956-M19703230005 460956-M19703230006 460956-M19703230007 460956-M19703230008 460956-M19703230009 460956-M19703230010 460956-M19703230011 460956-M19703230012 460956-M19703230013 460956-M19703230014 460956-M19703230015 460956-M19703230016 460956-M19703230017 460956-M19703230…
UPC codes
06944413800434

Products covered by this recall

Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express 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 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.

  • 06944413800434

Lot or batch code

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

  • 460430-M16105660001 460430-M16700280001 460475-M16605590001 4604

Model or item number

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

  • F6
  • F9
  • F6 Express

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 — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  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.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

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 06944413800434; lot code 460430-M16105660001 460430-M16700280001 460475-M16605590001 4604; model number F6, F9, F6 Express. 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?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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