Edan Diagnostics

FDA recalling firm · 3 enforcement events · 18 product records · 2016–2025 · CA

Edan Diagnostics has 3 FDA enforcement events on this register (18 product records) between 2016 and 2025: 3 device; the busiest year was 2016 with 1.

0% of its events are Class I; the most common class is Class II (3). 1 event is listed as ongoing; the recalling firm's address is in CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
24 Oct 2025	Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during…	Device	Class II	16	Ongoing
17 Nov 2017	EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital environments, including CCU and general wards (as Cardiology Dept.)	Device	Class II	1	Terminated
23 Jun 2016	EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and iM60 Vet, iM70 Vet Veterinary Monitors EtCO2 module is an optional component of the following machines: iM80, iM50, M50, iM70, iM60 and iM8, iM8A, iM8B, iM60 Vet, iM70 Vet Monitors, and is intended to…	Device	Class II	1	Terminated

By type and class

Device3

Class II3

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Edan Diagnostics by year initiated.

Questions and answers

How many FDA recalls has Edan Diagnostics had?

3 enforcement events (18 product records) on this register, 2016–2025: 3 device.

Are any Edan Diagnostics recalls ongoing?

1 event is listed as ongoing in the current openFDA export.

What class are Edan Diagnostics recalls?

3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.