Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog… — Class II medical device recall Z-1153-2026
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-1153-2026 |
|---|---|
| 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 | 12,201 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 06944413800786 |
| Lot numbers | 260084-M16408640001, 260084-M16408640002, 260084-M16408640003, 260084-M16408640004, 260084-M16408640005, 260084-M16408640006, 260084-M16408640007, 260084-M16408640008, 260084-M16408640009, 260084-M16408640010, 260084-M16408640011, 260084-M16408640012, 260084-M16408640013, 260084-M16408640014, 260084-M16408640015, 260084-M16408640016, 260084-M16408640017, 260084-M16408640018, 260084-M16408640019, 260084-M16408640020, 260084-M16408640021, 260084-M16408640022, 260084-M16408640023, 260084-M16408640024, 260084-M16408640025, 260084-M16408640026, 260084-M16408640027, 260084-M16408640028, 260084-M16408640029, 260084-M16408640030, 260084-M16B03200001, 260084-M16B03200002, 260084-M16B03200003, 260084-M16B03200004, 260084-M16B03200005, 260084-M16B03200006, 260084-M16B03200007, 260084-M16B03200008, 260084-M16B03200009, 260084-M16B03200010 and 460 more |
| Model numbers | M3A |
Product
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-invasive blood pressure (NIBP), the oxygen saturation of the blood (SpO2) and Rectal/Oral/Auxiliary/Ear temperature measurement. 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-1153-2026. 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.