Class II U.S. Food and Drug Administration

Brand Name: EDAN Product Name: Central Monitoring System 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-1150-2026
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
195
Distribution
Nationwide
Made in
United States
Lot / code info
EDAN Model: MFM-CMS UDI-DI code: 06944413800229 Serial/Lot Numbers: 261432-M18312480001 261432-M18803430001 261432-M18B04070001 261432-M18B04070002 261432-M18C06730001 261432-M18C06730002 261432-M18C06730004 261432-M18C06730003 261432-M18C06730005 261432-M18C06730006 261432-M19402160001 261432-M19402160003 261432-M19402160002 261432-M19B02530001 261432-M19B02530006 261432-M19A10370007 261432-M19B02530005 261432-M19B02530003 261432-M19B02530002 261432-M20213550006 261432-M20213550005 261432-M20213550003 261432-M20213550002 261432-M20213550004 261432-M20213550001 261432-M20702060001 261432-M20702060006 261432-M20702060002 261432-M20702060004 261432-M20702060007 261432-M20702060005 261432-M20708340003 261432-M20708340005 261432-M20708340002 261432-M20708340004 261432-M20708340001 261432-M20708340006 261432-M20810650003 261432-M20810650004 261432-M20810650002 261432-M20810650001 261432-M20810650006 261432-M20810650005 261432-M18401960001 261432-M20C04930001 261432-M20C04930002 261432-M20C04930005 261432-M20C04930004 261432-M20C04930003 261432-M20C04930006 261432-M21111490005 261432-M21111490004 261432-M21111490003 261432-M21111490002 261432-M21111490006 261432-M21111490001 261432-M21206490002 261432-M21206490006 261432-M21206490001 261432-M21206490005 261432-M21206490004 261432-M21206490003 261432-M21409870005 261432-M21409870003 261432-M21409870004 261432-M21409870001 261432-M21409870002 261432-M21409870006 261432-M21509140001 261432-M21509140003 261432-M21509140005 261432-M21509140004 261432-M21509140006 261432-M21509140002 261432-M21706970007 261432-M21706970008 261432-M21706970005 261432-M21706970001 261432-M21706970004 261432-M21706970006 261432-M21809930002 261432-M21909020003 261432-M21909020004 261432-M21909020002 261432-M21810820020 261432-M21810820006 261432-M21810820003 261432-M21809930005 261432-M21809930004 261432-M21809930003 261432-M21809930001 261432-M21909020001 261432-M18400410002 261432-M18310890001 261432-M18501600001 261432-M18802330001 261432-M19912390001 261432-M20412240001 261432-M20708340007 261432-M20915430001 261432-M20B09110001 261432-M20B13840001 261432-M20C10170001 261432-M21204410002 261432-M21204410003 261432-M21204410004 261432-M21204410001 261432-M21306400002 261432-M21306400003 261432-M21306400001 261432-M21316340001 261432-M21404840001 261432-M21512920002 261432-M21512920001 261432-M21615470001 261432-M21702760001 114M2330484 114M2330484 114M2330484 114M2330484 114M2330484 114M2330484 114M2330484 114M2370760 114M2370760 114M2370760 114M2370760 114M2370760 114M2370760 114M2370760 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1625 267M23B1625 267M23B1625 267M23B1625 267M23B1625 267M23B1625 267M23B1625 114M23B0232 114M23B0232 114M23B0232 114M23B0232 114M23B0232 114M23B0232 114M23B0232 114M23B0232 EDAN Model: MFM-CMS UDI-DI code: 06944413814264 Serial/Lot Numbers: 262237-M24611330012 262237-M24611330001 262237-M24611330011 262237-M24611330014 262237-M24611330009 262237-M24611330019 262237-M24611330004 262237-M24611330008 262237-M24611330007 262237-M24611330017 262237-M24611330010 262237-M24611330003 262237-M24611330005 262237-M24611330015 262237-M24611330013 262237-M24611330018 262237-M24611330002 262237-M24611330006 262237-M24611330016 262237-M24814380001 262237-M24905030001 262237-M24C17400001 262237-M24C17400003 262237-M24C17400004 262237-M24C17400002 262237-M24C17400005 MRM-CMSIII 262237-M24B06940008 262237-M24B06940001 262237-M24B06940003 262237-M24B06940005 262237-M24B06940010 262237-M24B06940004 262237-M24B06940007 262237-M24B06940006 262237-M24B06940002 262237-M24B06940009
UPC codes
06944413800229, 06944413814264

Products covered by this recall

Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring system product, which can connect and manage information from EDAN medical devices. MFM-CMS offers central management for monitoring information from the medical devices. All these collected information can be displayed, printed, alarmed and recorded. 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.

  • 06944413800229
  • 06944413814264

Lot or batch code

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

  • 261432-M18312480001 261432-M18803430001 261432-M18B04070001 2614
  • 262237-M24611330012 262237-M24611330001 262237-M24611330011 2622

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. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

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 06944413800229, 06944413814264; lot code 261432-M18312480001 261432-M18803430001 261432-M18B04070001 2614, 262237-M24611330012 262237-M24611330001 262237-M24611330011 2622. 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.

Related recalls