EKOS Corporation

Complete recall history across all FDA and CPSC categories — 6 total recalls

EKOS Corporation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (6)

FDA medical device enforcement actions by EKOS Corporation

Date Product Reason Class
Aug 22, 2016 The EKOS cart has the catalog number 700-60101. The EKOS cart is a custom ... Casters on the EKOS carts may be missing washers which can cause premature we... Class II
Aug 9, 2016 EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter The recalling firm identified ten devices which were distributed and could po... Class II
Jan 21, 2016 EkoSonic Endovascular System, Catalog Number 500-56112. It consists of thr... The EkoSonic kit, including the individually labeled MicroSonic Device (MSD) ... Class II
Jun 24, 2015 The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSo... The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B ... Class II
Oct 2, 2013 The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low powe... The EkoSonic Control Unit is recalled because it had the incorrect power entr... Class II
May 24, 2012 EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118;... EKOS Corporation have recently received several complaints from users where t... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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