Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog… — Class II medical device recall Z-1155-2026
Ongoing recall by Edan Diagnostics, reported 2026-01-28, distributed nationwide. As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybers
| Recall number | Z-1155-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edan Diagnostics, San Diego, CA, United States |
| Recall initiated | 2025-10-24 |
| Classified | 2026-01-22 |
| Reported by FDA | 2026-01-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX |
| Quantity | 1,457 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 06944413802261 |
| Lot numbers | 260638-M17211500001, 260638-M17211500002, 260638-M17211500003, 260638-M17211500004, 260881-M18402950001, 260881-M18407300001, 260881-M18407300002, 260881-M18407310001, 260881-M18407310002, 260881-M18412030001, 260881-M18606100001, 260881-M18606100002, 260881-M18606100003, 260881-M18606100004, 260881-M18606110001, 260881-M18606110005, 260881-M18703320001, 260881-M18703320002, 260881-M18703320003, 260881-M18703320004, 260881-M18800890001, 260881-M18800890002, 260881-M18800890003, 260881-M18800890004, 260881-M18800890005, 260881-M18800890006, 260881-M18800890007, 260881-M18800890008, 260881-M18800890009, 260881-M18800890010, 260881-M18810400001, 260881-M18810400002, 260881-M18810400003, 260881-M18810400004, 260881-M18810400005, 260881-M18810400006, 260881-M18810400007, 260881-M18810400008, 260881-M18810400009, 260881-M18810400010 and 460 more |
| Model numbers | IT20 |
Product
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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1155-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.