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

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-1142-2026
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
13934
Distribution
Nationwide
Made in
United States
Lot / code info
EDAN Model: M3 UDI-DI code: 06944413800618 Serial/Lot Number: 302050-M16200560001 302050-M16200560002 302089-M16203830017 302089-M16203830006 302089-M16203830020 302127-M15B11010006 302127-M16203840001 302127-M16203840002 302127-M16203840003 302127-M16203840004 302127-M16203840005 302127-M16203840006 302127-M16203840007 302127-M16203840008 302127-M16203840009 302127-M16203840010 302127-M16203840011 302127-M16203840012 302127-M16203840013 302127-M16203840014 302089-M16203830019 302089-M16203830018 302089-M16203830016 302089-M16203830015 302089-M16203830014 302089-M16203830013 302089-M16203830012 302089-M16203830011 302089-M16203830010 302089-M16203830008 302089-M16203830007 302089-M16203830005 302089-M16203830004 302089-M16203830009 302050-M16203850007 302089-M16203830003 302050-M16203850001 302089-M16203830002 302089-M16203830001 302050-M16203850010 302050-M16203850009 302050-M16203850008 302050-M16203850002 302050-M16203850006 302050-M16203850005 302050-M16203850004 302050-M16203850003 302050-M16407160008 302050-M16407160007 302050-M16407160006 302050-M16407160005 302050-M16407160004 302050-M16407160003 302050-M16407160002 302050-M16407160001 302050-M16407160009 302050-M16407160010 302127-M16407150005 302127-M16407150004 302127-M16407150003 302127-M16407150002 302127-M16407150001 302089-M16407140001 302089-M16407140002 302089-M16407140004 302089-M16407140005 302089-M16407140006 302089-M16407140007 302089-M16407140008 302089-M16407140009 302089-M16407140010 302089-M16407140003 302050-M16802330001 302050-M16802330002 302050-M16802330003 302089-M16802340010 302050-M16802330004 302050-M16802330005 302050-M16802330006 302050-M16802330007 302050-M16802330008 302050-M16802330009 302050-M16802330010 302050-M16802330011 302050-M16802330012 302050-M16802330013 302050-M16802330015 302089-M16802340001 302089-M16802340002 302089-M16802340003 302089-M16802340004 302089-M16802340005 302089-M16802340006 302089-M16802340007 302089-M16802340008 302050-M16802330014 302089-M16802340009 302050-M16B08880011 302050-M16B08880010 302050-M16B08880009 302050-M16B08880008 302050-M16B08880007 302050-M16B08880006 302050-M16B08880005 302050-M16B08880004 302050-M16B08880003 302050-M16B08880002 302050-M16B08880001 302050-M16B08880012 302050-M16B08880013 302050-M16B11070002 302050-M16B11070005 302050-M16B11070004 302050-M16B11070003 302050-M16B11070001 302050-M16C02360005 302050-M16C02360004 302050-M16C02360003 302050-M16C02360001 302050-M16C02360002 302050-M16B08890012 302050-M16B08890011 302050-M16B08890008 302050-M16B08890009 302050-M16B08890010 302050-M16B08890001 302050-M16B08890002 302050-M16B08890003 302050-M16B08890004 302050-M16B08890005 302050-M16B08890006 302050-M16B08890007 302089-M17100570003 302089-M17100570002 302089-M17100570004 302089-M17100570005 302089-M17100570001 302122-M17202660003 302122-M17202660005 302122-M17202660002 302050-M17202650003 302122-M17202660004 302050-M17202650004 302050-M17202650002 302050-M17202650001 302122-M17202660001 302050-M17202650005 302089-M17201870019 302089-M17201870018 302089-M17201870017 302089-M17201870013 302089-M17201870012 302089-M17201870011 302050-M17201860018 302050-M17201860016 302050-M17201860010 302050-M17201860006 302050-M17201860003 302050-M17201860004 302050-M17201860013 302050-M17201860014 302089-M17201870022 302089-M17201870005 302089-M17201870004 302089-M17201870021 302089-M17201870006 302050-M17201860021 302050-M17201860015 302050-M17201860024 302050-M17201860011 302050-M17201860009 302050-M17201860025 302089-M17201870020 302089-M17201870001 302089-M17201870015 302050-M17201860022 302050-M17201860020 302050-M17201860019 302050-M17201860017 302050-M17201860007 302050-M17201860005 302089-M17201870014 302089-M17201870002 302089-M17201870003 302089-M17201870007 302050-M17201860023 302050-M17201860008 302050-M17201860012 302050-M17201860002 302050-M17201860001 302089-M17201870025 302089-M17201870024 302089-M17201870023 302089-M17201870016 302089-M17201870010 302089-M17201870009 302089-M172018700…
UPC codes
06944413800618

Products covered by this recall

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 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.

  • 06944413800618

Lot or batch code

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

  • 302050-M16200560001 302050-M16200560002 302089-M16203830017 3020

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 06944413800618; lot code 302050-M16200560001 302050-M16200560002 302089-M16203830017 3020. 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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