FDA Device recall Z-1142-2026
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Monitor is a portable devi…
- FDA Device
- Class II
- ongoing
- Published 2026-01-28
On 2026-01-28 the FDA classified a Class II recall of Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Monitor is a portable devi… by Edan Diagnostics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1142-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-24 |
| Published | 2026-01-28 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Edan Diagnostics |
| Distribution | US |
Product
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 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
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.
Identifiers
| code_info | EDAN Model: M3 UDI-DI code: 06944413800618 Serial/Lot Number: 302050-M16200560001 302050-M16200560002 302089-M162038300…EDAN Model: M3 UDI-DI code: 06944413800618 Serial/Lot Number: 302050-M16200560001 302050-M16200560002 302089-M16203830017 302089-M16203830006 302089-M16203830020 302127-M15B11010006 302127-M16203840001 302127-M16203840002 302127-M16203840003 302127-M16203840004 302127-M16203840005 302127-M16203840006 302127-M16203840007 302127-M16203840008 302127-M16203840009 302127-M16203840010 302127-M16203840011 302127-M16203840012 302127-M16203840013 302127-M16203840014 302089-M16203830019 302089-M16203830018 302089-M16203830016 302089-M16203830015 302089-M16203830014 302089-M16203830013 302089-M16203830012 302089-M16203830011 302089-M16203830010 302089-M16203830008 302089-M16203830007 302089-M16203830005 302089-M16203830004 302089-M16203830009 302050-M16203850007 302089-M16203830003 302050-M16203850001 302089-M16203830002 302089-M16203830001 302050-M16203850010 302050-M16203850009 302050-M16203850008 302050-M16203850002 302050-M16203850006 302050-M16203850005 302050-M16203850004 302050-M1620385000 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1142-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.