Edan Diagnostics
San Diego, CA
This page shows every FDA and USDA recall linked to Edan Diagnostics. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
18
Total Recalls
2016
First Recall
2026
Most Recent
Brand Name: EDAN
Product Name: Fetal Monitor
Model/Catalog Number: F2, F3
Product Description: The devices are...
Jan 22, 2026
· Device
Open, Classified
Brand Name: EDAN
Product Name: Vital Signs Monitor
Model/Catalog Number: M3A
Product Description: The Vital Si...
Jan 22, 2026
· Device
Open, Classified
Brand Name: EDAN
Product Name: Patient Monitor
Model/Catalog Number: elite V5, elite V6, elite V8
Product Desc...
Jan 22, 2026
· Device
Open, Classified
Brand Name: EDAN
Product Name: Patient Monitor
Model/Catalog Number: iX10, iX12, iX15
Product Description: The...
Jan 22, 2026
· Device
Open, Classified
Brand Name: EDAN
Product Name: Fetal & Maternal Monitor
Model/Catalog Number: F6, F9, F6 Express, F9 Express
P...
Jan 22, 2026
· Device
Open, Classified
Brand Name: EDAN
Product Name: Vital Signs Monitor
Model/Catalog Number: M3
Product Description: The Vital Sig...
Jan 22, 2026
· Device
Open, Classified
Brand Name: EDAN
Product Name: Patient Monitor
Model/Catalog Number: iM50, iM60, iM70, iM80
Product Descriptio...
Jan 22, 2026
· Device
Open, Classified
Brand Name: EDAN
Product Name: Vital Signs Monitor
Model/Catalog Number: M3B
Product Description: M3B Vital Si...
Jan 22, 2026
· Device
Open, Classified
Brand Name: EDAN
Product Name: Vital Signs Monitor
Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s
Product Des...
Jan 22, 2026
· Device
Open, Classified
Brand Name: EDAN
Product Name: Central Monitoring System
Model/Catalog Number: MFM-CMS
Product Description: MF...
Jan 22, 2026
· Device
Open, Classified
Brand Name: EDAN
Product Name: Telemetry Transmitter
Model/Catalog Number: iT20
Product Description: iT20 coll...
Jan 22, 2026
· Device
Open, Classified
Brand Name: EDAN
Product Name: Patient Monitor
Model/Catalog Number: iM20
Product Description: The iM20 Patien...
Jan 22, 2026
· Device
Open, Classified
Brand Name: EDAN
Product Name: Central Monitoring System
Model/Catalog Number: MFM-CNS, MFM-CNS Lite
Product D...
Jan 22, 2026
· Device
Open, Classified
Brand Name: EDAN
Product Name: Patient Monitor
Model/Catalog Number: X8, X10, X12
Product Description: The X8...
Jan 22, 2026
· Device
Open, Classified
Brand Name: EDAN
Product Name: Patient Monitor
Model/Catalog Number: iM8, iM8A, iM8B
Product Description: iM8...
Jan 22, 2026
· Device
Open, Classified
Brand Name: EDAN
Product Name: Vital Signs Monitor
Model/Catalog Number: iM3
Product Description: The iM3 has...
Jan 22, 2026
· Device
Open, Classified
EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used...
Feb 18, 2020
· Device
Terminated
EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitor...
Jun 23, 2016
· Device
Terminated