Reported Jan 28, 2026 · Ongoing
Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects…
Edan Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edan Diagnostics · 9833 Pacific Heights Blvd · San Diego, CA · 92121-4707
Is this the product you have?
- Brand NameEDAN
- Product NameTelemetry
- Transmitter Model/Catalog NumberiT20
- Product DescriptioniT20 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
- ComponentNo
- Lot codes and dates
- EDAN ModeliT20
- UDI-DI code06944413802261
- Serial/Lot Numbers
1,457 of 1,457 codes
261350-M17A03030002261350-M17A03030001260881-M18407300001260881-M18407300002260881-M18407310002260881-M18407310001260881-M18703320002260881-M18703320004260881-M18703320001260881-M18703320003260881-M18800890008260881-M18800890003260881-M18800890004260881-M18800890005260881-M18800890007260881-M18800890001260881-M18800890006260881-M18800890002260881-M18800890010260881-M18810400010260881-M18810400009260881-M18810400008260881-M18810400004260881-M18810400003260881-M18810410008260881-M18810410006260881-M18810410002260881-M18810400007260881-M18810400002260881-M18810400001260881-M18810410003260881-M18810410007260881-M18810410001260881-M18810410010260881-M18810410005260881-M18810410009260881-M18810410004260881-M18810400005260881-M18810400006260881-M18901010006260881-M18901000007260881-M18901000009260881-M18901000012260881-M18901000017260881-M18901000018260881-M18901000002260881-M18901010002260881-M18901010001260881-M18901000003260881-M18901000013260881-M18901000005260881-M18901010003260881-M18901010004260881-M18901010005260881-M18901000015260881-M18901010008260881-M18901010007260881-M18901000006260881-M18901000016260881-M18901000001
- Amount recalled
- 1457
This recall covers 16 products
The agency filed one notice per product. You are reading one of them; the other 15 are below.
3 more are in the archive.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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