Edan Diagnostics recalls

Edan Diagnostics has 11 recalls on record with the FDA and USDA, the earliest in 2016 and the latest reported on 28 Jan 2026. 9 are still ongoing. 9 were reported in the last 12 months. The most frequent reason is device malfunction.

Total recalls11since 2016

Last 12 months9reported

Class I00% of total

Ongoing9latest 28 Jan 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 9Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 11 100%Class III 0 0%

Why edan diagnostics is recalled

Product types

Patient Monitors1091%
CPAP & Ventilators19%

By year

2026982%
202019%
201619%

Ongoing edan diagnostics recalls

9 active

Reported	Class	Recall	Company	Reason	Where
28 Jan 2026Device	CLASS II	EDAN Patient Monitor recalled by Edan Diagnostics	Edan Diagnostics	Temperature Abuse	Nationwide
28 Jan 2026Device	CLASS II	EDAN Central Monitoring System recalled by Edan Diagnostics	Edan Diagnostics	Device Malfunction	Nationwide
28 Jan 2026Device	CLASS II	EDAN Vital Signs Monitor recalled by Edan Diagnostics	Edan Diagnostics	Other	Nationwide
28 Jan 2026Device	CLASS II	EDAN Vital Signs Monitor recalled by Edan Diagnostics	Edan Diagnostics	Other	Nationwide
28 Jan 2026Device	CLASS II	EDAN Patient Monitor recalled by Edan Diagnostics	Edan Diagnostics	Device Malfunction	Nationwide
28 Jan 2026Device	CLASS II	EDAN Patient Monitor recalled by Edan Diagnostics	Edan Diagnostics	Device Malfunction	Nationwide

All edan diagnostics recalls, newest first

11 total

Reported	Class	Recall	Company	Reason	Where
28 Jan 2026Device	CLASS II	EDAN Patient Monitor recalled by Edan Diagnostics	Edan Diagnostics	Temperature Abuse	Nationwide
28 Jan 2026Device	CLASS II	EDAN Central Monitoring System recalled by Edan Diagnostics	Edan Diagnostics	Device Malfunction	Nationwide
28 Jan 2026Device	CLASS II	EDAN Vital Signs Monitor recalled by Edan Diagnostics	Edan Diagnostics	Other	Nationwide
28 Jan 2026Device	CLASS II	EDAN Vital Signs Monitor recalled by Edan Diagnostics	Edan Diagnostics	Other	Nationwide
28 Jan 2026Device	CLASS II	EDAN Patient Monitor recalled by Edan Diagnostics	Edan Diagnostics	Device Malfunction	Nationwide
28 Jan 2026Device	CLASS II	EDAN Patient Monitor recalled by Edan Diagnostics	Edan Diagnostics	Device Malfunction	Nationwide
28 Jan 2026Device	CLASS II	EDAN Patient Monitor recalled by Edan Diagnostics	Edan Diagnostics	Device Malfunction	Nationwide
28 Jan 2026Device	CLASS II	EDAN Telemetry Transmitter recalled by Edan Diagnostics	Edan Diagnostics	Device Malfunction	Nationwide
28 Jan 2026Device	CLASS II	EDAN Central Monitoring System recalled by Edan Diagnostics	Edan Diagnostics	Device Malfunction	Nationwide
26 Feb 2020Device	CLASS II	EDAN Telemetry Transmitter recalled by Edan Diagnostics	Edan Diagnostics	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.