Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2 — Class II medical device recall Z-1140-2026
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-1140-2026 |
|---|---|
| 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 | 3,721 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 06944413800847, 06944413800861 |
| Lot numbers | 007, 460085-M16105760001, 460085-M16105760002, 460085-M16105760003, 460085-M16105760004, 460085-M16105760005, 460085-M16105760006, 460085-M16105760007, 460085-M16105760008, 460085-M16105760009, 460085-M16105760010, 460085-M16105760011, 460085-M16105760012, 460085-M16105760013, 460085-M16105760014, 460085-M16105760015, 460085-M16105760016, 460085-M16105760017, 460085-M16105760018, 460085-M16105760019, 460085-M16105760020, 460085-M16105760021, 460085-M16105760022, 460085-M16105760023, 460085-M16105760024, 460085-M16105760025, 460085-M16105760026, 460085-M16105760027, 460085-M16105760028, 460085-M16105760029, 460085-M16105760030, 460085-M16105760031, 460085-M16105760032, 460085-M16105760033, 460085-M16105760034, 460085-M16105760035, 460085-M16105760036, 460085-M16105760037, 460085-M16105760038, 460085-M16105760039 and 460 more |
Product
Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. 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-1140-2026. 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.