Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number:… — Class II medical device recall Z-1154-2026
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-1154-2026 |
|---|---|
| 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 | 3,141 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 06944413801592, 06944413801608, 06944413801615 |
| Lot numbers | 260133-M16905680001, 260133-M16905680002, 260133-M16906960001, 260133-M16906960002, 260605-K16300150001, 260605-K16300150002, 260605-K16300150003, 260605-K16300150004, 260605-K16300150005, 260605-K16300150006, 260605-K16300150007, 260605-K16300150008, 260605-K16300150009, 260605-K16300150010, 260605-M16304610001, 260605-M16304610002, 260605-M16304610003, 260605-M16304610004, 260605-M16304610005, 260605-M16304610006, 260605-M16304610007, 260605-M16304610008, 260605-M16304610009, 260605-M16304610010, 260605-M16313860001, 260605-M16313860002, 260605-M16313860003, 260605-M16313860004, 260605-M16313860005, 260605-M16313860006, 260605-M16313860007, 260605-M16313860008, 260605-M16313860009, 260605-M16313860010, 260605-M16313860011, 260605-M16313860012, 260605-M16313860013, 260605-M16313860014, 260605-M16313860015, 260605-M16313860016 and 460 more |
| Model numbers | IM8, IM8A, IM8B |
Product
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. The patient monitor supports software upgrade online and networking and build-in battery power is available for all the models. iM8 Series Patient Monitor can monitor physiological parameters including SpO2, NIBP, ECG, RESP, TEMP, CO2, IBP. The above is the maximum configuration, the user may select different monitoring parameters in according with the requirement. iM8 Series patient monitor includes three models iM8, iM8A, iM8B, and screen size is the primary difference for three models. 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-1154-2026. 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.