Recall Register

Food, drugs, devices › Firms

EKOS Corporation

FDA recalling firm · 6 enforcement events · 6 product records · 2012–2016 · WA

EKOS Corporation has 6 FDA enforcement events on this register (6 product records) between 2012 and 2016: 6 device; the busiest year was 2016 with 3.

0% of its events are Class I; the most common class is Class II (6). 0 events are listed as ongoing; the recalling firm's address is in WA.

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

InitiatedProduct (first record)TypeClassRecordsStatus
22 Aug 2016The EKOS cart has the catalog number 700-60101. The EKOS cart is a custom infusion stand/cart used to hold and transport the EkoSonic Control Unit. The cart is designed with three poles to hold infusion pumps and fluid bags, a tray on which the EkoSonic Control unit sits and a base designed to hold an Uninterruptable…DeviceClass II1Terminated
9 Aug 2016EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery CatheterDeviceClass II1Terminated
21 Jan 2016EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and removable MicroSonic Device (MSD), and a reusable EKOS EkoSonic Control System. During use, fluids are…DeviceClass II1Terminated
24 Jun 2015The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. The EkoSonic Endovascular System consists of three main components: -a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter…DeviceClass II1Terminated
2 Oct 2013The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per transducer) ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature and to deliver solutions into the pulmonary arteries. The EkoSonic Endovascular System is intended…DeviceClass II1Terminated
24 May 2012EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; 500-55140; 500-55150; 500-54106; 500-56130; 500-56140; 500-56150) is a catheter, continuous infusion. it consists of the Intelligent Drug Delivery Catheter (IDDC) and the MicroSonic Device (MSD). It is intended for the…DeviceClass II1Terminated

By type and class

Device6
Class II6

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

Events by year

12
14
16
18
20
22
24
26
Enforcement events for EKOS Corporation by year initiated.

Questions and answers

How many FDA recalls has EKOS Corporation had?

6 enforcement events (6 product records) on this register, 2012–2016: 6 device.

Are any EKOS Corporation recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are EKOS Corporation recalls?

6 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.