FDA Device recall Z-1152-2026
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient moni…
- 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: M3B Product Description: M3B Vital Signs Monitor is a patient moni… 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-1152-2026 |
| 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: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of arterial blood oxygen saturation (SpO2), Pulse Rate and CO2 in a hospital, hospital type facilities environment and intra-hospital moves. 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: M3B UDI-DI code: 06944413800625 Serial/Lot Numbers: 302135-M16304900001 302135-M16304900002 261184-K1740019…EDAN Model: M3B UDI-DI code: 06944413800625 Serial/Lot Numbers: 302135-M16304900001 302135-M16304900002 261184-K17400190004 261184-K17400190001 261184-K17400190006 261184-K17400190002 261184-K17400190005 261184-K17400190003 261184-M17A03040001 261184-M18502370001 360126-M18810390001 360126-M18A08360001 360126-M18B13740001 360126-M19302070001 360126-M19302070002 360126-M19302070004 360126-M19302070003 360126-M20310110001 360126-M20310110002 360126-M20507230004 360126-M20507230003 360126-M20507230002 360126-M20507230001 360126-M20507230010 360126-M20507230007 360126-M20507230006 360126-M20507230008 360126-M20507230009 360126-M20507230005 360126-M23226940004 360126-M23226940005 360126-M23226940003 360126-M23226940001 360126-M23226940002 360126-M24511420002 360126-M24511420001 360126-M24716380001 360126-M24716380002 360126-M24716380003 360126-M24716380004 360126-M24716380005 302135-M16403060001 302135-M16403060002 302135-M16403060003 302135-M16403060004 302135-M16901880001 302135-M16901880 |
|---|
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-1152-2026%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.