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

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-1152-2026
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
354
Distribution
Nationwide
Made in
United States
Lot / code info
EDAN Model: M3B UDI-DI code: 06944413800625 Serial/Lot Numbers: 302135-M16304900001 302135-M16304900002 261184-K17400190004 261184-K17400190001 261184-K17400190006 261184-K17400190002 261184-K17400190005 261184-K17400190003 261184-M17A03040001 261184-M18502370001 360126-M18810390001 360126-M18A08360001 360126-M18B13740001 360126-M19302070001 360126-M19302070002 360126-M19302070004 360126-M19302070003 360126-M20310110001 360126-M20310110002 360126-M20507230004 360126-M20507230003 360126-M20507230002 360126-M20507230001 360126-M20507230010 360126-M20507230007 360126-M20507230006 360126-M20507230008 360126-M20507230009 360126-M20507230005 360126-M23226940004 360126-M23226940005 360126-M23226940003 360126-M23226940001 360126-M23226940002 360126-M24511420002 360126-M24511420001 360126-M24716380001 360126-M24716380002 360126-M24716380003 360126-M24716380004 360126-M24716380005 302135-M16403060001 302135-M16403060002 302135-M16403060003 302135-M16403060004 302135-M16901880001 302135-M16901880002 302135-M16901880003 360126-M19805440001 360126-M19805440002 360126-M19805440003 360126-M19805440004 360126-M20A13020002 360126-M20A13020001 360126-M20C18100001 360126-M21113380001 360126-M21404350001 360126-K23100140005 360126-K23100140004 360126-K23100140006 360126-K23100140001 360126-K23100140002 360126-K23100140003 360126-K23200180002 360126-K23200180003 360126-K23200180004 360126-M23222190005 360126-M23222190004 360126-M23222190002 360126-K23200180005 360126-K23200180001 360126-M23222190001 360126-M23222190003 360126-M23402080001 360126-M23402080004 360126-M23402080003 360126-M23402080002 360126-M23402080005 360126-M23402080006 360126-M23810550001 360126-M24308270001 302110-M15A04280003 302110-M15A04280004 302110-M15A04280005 302110-M15A04280002 302110-M15A04280001 302110-M15B04370012 302110-M15B04370013 302110-M15B04370015 302110-M15B04370001 302110-M15B04370002 302110-M15B04370003 302110-M15B04370004 302110-M15B04370007 302110-M15B04370006 302110-M15B04370014 302110-M15B04370008 302110-M15B04370009 302110-M15B04370010 302110-M15B04370011 302110-M15B04370005 260614-M15B05770001 302052-M15C01120005 302052-M15C01120004 302052-M15C01120003 302052-M15C01120001 302052-M15C01120002 302052-M16410920005 302052-M16410920004 302052-M16410920003 302052-M16410920002 302052-M16410920001 261036-M16B04590021 261036-M16B04590020 261036-M16B04590019 261036-M16B04590018 261036-M16B04590017 261036-M16B04590016 261036-M16B04590013 261036-M16B04590014 261036-M16B04590022 261036-M16B04590012 261036-M16B04590011 261036-M16B04590010 261036-M16B04590009 261036-M16B04590015 261036-M16B04590023 261036-M16B04590027 261036-M16B04590025 261036-M16B04590026 261036-M16B04590028 261036-M16B04590029 261036-M16B04590030 261036-M16B04590008 261036-M16B04590006 261036-M16B04590005 261036-M16B04590004 261036-M16B04590003 261036-M16B04590002 261036-M16B04590001 261036-M16B04590024 261036-M16B04590007 261038-M16B08500001 261038-M17101560001 261038-M17101560002 261038-M17101560004 261038-M17101560003 261038-M17101560005 260134-M17109090001 261036-M17207750009 261036-M17207750010 261036-M17207750001 261036-M17207750007 261036-M17207750008 261036-M17207750004 261036-M17207750006 261036-M17207750005 261036-M17207750003 261036-M17207750002 3021320-M17300950001 3021320-M17304090003 3021320-M17304090002 3021320-M17304090001 3021320-M17304100001 261036-M17309070013 261036-M17309070006 261036-M17309070019 261036-M17309070017 261036-M17309070011 261036-M17309070003 261036-M17309070020 261036-M17309070010 261036-M17309070018 261036-M17309070012 261036-M17309070004 261036-M17309070005 261036-M17309070009 261036-M17309070014 261036-M17309070008 261036-M17309070001 261036-M17309070002 261036-M17309070007 261036-M17309070015 261036-M17309070016 3021320-M17402010001 3021320-M17606210004 3021320-M17606210001 3021320-M17606210003 3021320-M17606210002 302121-M17806460005 302121-M17806460001 302121-M17806460003 302121-M17806460004 302121-M17806460002 261038-M18108080001 360126-M18112880003 36012…
UPC codes
06944413800625

Products covered by this recall

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of arterial blood oxygen saturation (SpO2), Pulse Rate and CO2 in a hospital, hospital type facilities environment and intra-hospital moves. 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.

  • 06944413800625

Lot or batch code

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

  • 302135-M16304900001 302135-M16304900002 261184-K17400190004 2611

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. 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.

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 06944413800625; lot code 302135-M16304900001 302135-M16304900002 261184-K17400190004 2611. 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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