Class II U.S. Food and Drug Administration

Brand Name: EDAN Product Name: Patient 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-1148-2026
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
3824
Distribution
Nationwide
Made in
United States
Lot / code info
EDAN Model: X8 UDI-DI code: 06944413810907 Serial/Lot Numbers: 261586-M21116620010 261586-M21116620002 261586-M21116620007 261586-M21116620006 261586-M21116620009 261586-M21116630001 261586-M21116620008 261586-M21116620003 261586-M21116630005 261586-M21116630003 261586-M21116620004 261586-M21116620001 261586-M21116630004 261586-M21116630002 261586-M21116620005 261586-M21301970003 261586-M21301970004 261586-M21301960001 261586-M21301970005 261586-M21301960003 261586-M21301970002 261586-M21301970001 261586-M21301960002 261586-M21714500002 261586-M21714500001 261586-M21714500003 261586-M21816750005 261586-M21816750003 261586-M21816750002 261586-M21816750004 261586-M21816750001 261586-M22105750001 261586-M22105750007 261586-M22105750008 261586-M22105750010 261586-M22105750002 261586-M22105750005 261586-M22105750009 261586-M22105750006 261586-M22105750003 261586-M22105750004 261586-M22405430007 261586-M22405430001 261586-M22405430004 261586-M22405430010 261586-M22405430006 261586-M22405430009 261586-M22405430008 261586-M22405430003 261586-M22405430002 261586-M22405430005 261586-M22615270004 261586-M22615270005 261586-M22615270001 261586-M22615270002 261586-M22615270003 261586-M23226950003 261586-M23226950002 261586-M23226950004 261586-M23226950005 261586-M23226950001 261586-M23B18320003 261586-M23B18320004 261586-M23B18330001 261586-M23B18330002 261586-M23B18330003 261586-M23B18330004 261586-M23B18320001 261586-M23B18320005 261586-M23B18330005 261586-M23B18320002 261586-M23C15910003 261586-M23C15920001 261586-M23C15920005 261586-M23C15920004 261586-M23C15920009 261586-M23C15910002 261586-M23C15920010 261586-M23C15920002 261586-M23C15910001 261586-M23C15910005 261586-M23C15920006 261586-M23C15920003 261586-M23C15910004 261586-M23C15920008 261586-M23C15920007 261586-M24104080002 261586-M24104080010 261586-M24104080003 261586-M24104080004 261586-M24104080006 261586-M24104080001 261586-M24104080005 261586-M24104080008 261586-M24104080009 261586-M24104080007 261586-M20611590012 261586-M20611590007 261586-M20611570016 261586-M20611590017 261586-M20611590018 261586-M20611580019 261586-M20611590004 261586-M20611590006 261586-M20611580022 261586-M20611590011 261586-M20611580002 261586-M20611580007 261586-M20611580017 261586-M20611580009 261586-M20611590009 261586-M20611590008 261586-M20611590019 261586-M20611590003 261586-M20611570006 261586-M20611580024 261586-M20611560003 261586-M20611570017 261586-M20611570015 261586-M20611560017 261586-M20611560007 261586-M20611560025 261586-M20611560020 261586-M20611560014 261586-M20611560013 261586-M20611560004 261586-M20611560022 261586-M20611560021 261586-M20611560018 261586-M20611560009 261586-M20611580012 261586-M20611560008 261586-M20611560011 261586-M20611560010 261586-M20611560002 261586-M20611560001 261586-M20611560019 261586-M20611560015 261586-M20611560006 261586-M20611560005 261586-M20611560024 261586-M20611560023 261586-M20611560012 261586-M20611590005 261586-M20611580015 261586-M20611580025 261586-M20611560016 261586-M20611580014 261586-M20611570002 261586-M20611580004 261586-M20611580005 261586-M20611590010 261586-M20611590013 261586-M20611590014 261586-M20611590015 261586-M20611590016 261586-M20611570001 261586-M20611570005 261586-M20611570007 261586-M20611570009 261586-M20611570019 261586-M20611580003 261586-M20611580013 261586-M20611580018 261586-M20611570010 261586-M20611570012 261586-M20611570018 261586-M20611570020 261586-M20611580006 261586-M20611580016 261586-M20611580023 261586-M20611590002 261586-M20611590001 261586-M20611590020 261586-M20611580020 261586-M20611580021 261586-M20611570004 261586-M20611580001 261586-M20611580010 261586-M20611570008 261586-M20611570003 261586-M20611570011 261586-M20611570013 261586-M20611580008 261586-M20611580011 261586-M20611570014 261586-M21313600009 261586-M21313600020 261586-M21313600017 261586-M21313600013 261586-M21313600010 261586-M21313600007 261586-M21313600024 261586-M21313600006 261586-M21313600023 261586-M21313600021 261586-M21313600…
UPC codes
06944413810907

Products covered by this recall

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12 Patient Monitor (hereinafter called X series) can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. Component: No

Check your product

The notice names 4 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.

  • 06944413810907

Lot or batch code

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

  • 261586-M21116620010 261586-M21116620002 261586-M21116620007 2615

Model or item number

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

  • X8
  • X10

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 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.

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 06944413810907; lot code 261586-M21116620010 261586-M21116620002 261586-M21116620007 2615; model number X8, X10. 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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