Class II U.S. Food and Drug Administration

Brand Name: EDAN Product Name: Telemetry Transmitter 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-1155-2026
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
1457
Distribution
Nationwide
Made in
United States
Lot / code info
EDAN Model: iT20 UDI-DI code: 06944413802261 Serial/Lot Numbers: 261350-M17A03030002 261350-M17A03030001 260881-M18407300001 260881-M18407300002 260881-M18407310002 260881-M18407310001 260881-M18703320002 260881-M18703320004 260881-M18703320001 260881-M18703320003 260881-M18800890008 260881-M18800890003 260881-M18800890004 260881-M18800890005 260881-M18800890007 260881-M18800890001 260881-M18800890006 260881-M18800890002 260881-M18800890010 260881-M18810400010 260881-M18810400009 260881-M18810400008 260881-M18810400004 260881-M18810400003 260881-M18810410008 260881-M18810410006 260881-M18810410002 260881-M18810400007 260881-M18810400002 260881-M18810400001 260881-M18810410003 260881-M18810410007 260881-M18810410001 260881-M18810410010 260881-M18810410005 260881-M18810410009 260881-M18810410004 260881-M18810400005 260881-M18810400006 260881-M18901010006 260881-M18901000007 260881-M18901000009 260881-M18901000012 260881-M18901000017 260881-M18901000018 260881-M18901000002 260881-M18901010002 260881-M18901010001 260881-M18901000003 260881-M18901000013 260881-M18901000005 260881-M18901010003 260881-M18901010004 260881-M18901010005 260881-M18901000015 260881-M18901010008 260881-M18901010007 260881-M18901000006 260881-M18901000016 260881-M18901000001 260881-M18901000011 260881-M18901000019 260881-M18901000010 260881-M18901010010 260881-M18901000020 260881-M18901000014 260881-M18901000008 260881-M18901000004 260881-M18901010009 260881-M18905240010 260881-M18905240008 260881-M18905240009 260881-M18905240003 260881-M18905240001 260881-M18905240007 260881-M18905240006 260881-M18905240004 260881-M18905240005 260881-M18905240002 260881-M18A10840004 260881-M18A10830006 260881-M18A10830001 260881-M18A10830002 260881-M18A10830015 260881-M18A10830018 260881-M18A10830019 260881-M18A10830023 260881-M18A10830012 260881-M18A10830020 260881-M18A10830011 260881-M18A10830025 260881-M18A10830028 260881-M18A10830022 260881-M18A10830021 260881-M18A10830016 260881-M18A10840009 260881-M18A10840007 260881-M18A10840001 260881-M18A10830030 260881-M18A10830029 260881-M18A10840003 260881-M18A10830027 260881-M18A10840002 260881-M18A10840005 260881-M18A10840008 260881-M18A10840010 260881-M18A10830004 260881-M18A10830014 260881-M18A10830007 260881-M18A10830008 260881-M18A10830009 260881-M18A10830010 260881-M18A10830013 260881-M18A10830017 260881-M18A10830024 260881-M18A10830005 260881-M18A10830003 260881-M18A10840006 260881-M18A10830026 260881-M18B05540005 260881-M18B05540001 260881-M18B05540003 260881-M18B05540002 260881-M18B05540004 260881-M18C07740002 260881-M18C07740005 260881-M18C07740019 260881-M18C07740015 260881-M18C07740012 260881-M18C07740001 260881-M18C07740010 260881-M18C07740014 260881-M18C07740011 260881-M18C07740008 260881-M18C07740003 260881-M18C07740016 260881-M18C07740017 260881-M18C07740006 260881-M18C07740004 260881-M18C07740018 260881-M18C07740013 260881-M18C07740007 260881-M18C07740009 260881-M18C07740020 260881-M19B01570004 260881-M19B01570002 260881-M19B01570001 260881-M19B06640004 260881-M19B06640006 260881-M19B06640009 260881-M19B06640001 260881-M19B06640007 260881-M19B06640008 260881-M19B06640002 260881-M19B06640010 260881-M19C16950004 260881-M19C16950003 260881-M19C16950009 260881-M19C16960004 260881-M19C16950010 260881-M19C16960008 260881-M19C16960009 260881-M19C16950001 260881-M19C16950002 260881-M19C16950006 260881-M19C16960001 260881-M19C16960002 260881-M19C16960006 260881-M19C16960010 260881-M19C16950007 260881-M19C16950008 260881-M19C16950005 260881-M20214690034 260881-M20214690018 260881-M20214690037 260881-M20214690038 260881-M20214690020 260881-M20214690040 260881-M20214690028 260881-M20214690024 260881-M20214690032 260881-M20214690013 260881-M20214690027 260881-M20214690010 260881-M20214690035 260881-M20214690007 260881-M20214690003 260881-M20214690004 260881-M20214690033 260881-M20214690030 260881-M20214690019 260881-M20214690016 260881-M20214690015 260881-M20214690009 260881-M20214690005 260881-M20214690008 260881-M202146…
UPC codes
06944413802261

Products covered by this recall

Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects physiological parameters by ECG cables and SpO2 sensors, then achieves data analyzing and processing. After that, data will be sent to MFM-CMS via Wi-Fi. The parameters supported are ECG, SpO2 and PR. 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.

  • 06944413802261

Lot or batch code

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

  • 261350-M17A03030002 261350-M17A03030001 260881-M18407300001 2608

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. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

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 06944413802261; lot code 261350-M17A03030002 261350-M17A03030001 260881-M18407300001 2608. 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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