Lower riskMedical device recall · FDA · Published October 13, 2022
Boston Scientific EKOS Control Unit 4.0 Console Recall: Missing Instructions
Boston Scientific recalls EKOS Control Unit 4.0 consoles with missing or incorrect instructions. Affected units have specific serial numbers and GTIN. Consumers should contact the company for details.
“Boston Scientific EKOS Control Unit 4.0 Console Recall: Missing Instructions.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59919-boston-scientific-ekos-control-unit-4-0-console-recall-missing. Based on FDA recall #Z-0149-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0149-2023%22&limit=1).
The FDA announced on Oct. 13, 2022, that Boston Scientific Corporation voluntarily recalled EKOS Control Unit 4.0 consoles because they were shipped without an instruction for use or with the incorrect one. The recall affects 16 units distributed to several U.S. states and foreign countries.
How to tell if you have it
EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0
UPC 00858593006462
GTIN 00858593006462
Serial numbers CU4.0-01438, CU4.0-01524, CU4.0-01545, CU4.0-01560, CU4.0-01598, CU4.0-01610, CU4.0-01676, CU4.0-01804, CU4.0-01835, CU4.0-01840, CU4.0-01843, CU4.0-01897, CU4.0-01980, CU4.0-02022, CU4.0-02146, and CU4.0-02026
The hazard
According to the FDA, the recalled EKOS Control Unit 4.0 consoles were shipped without an instruction for use or with the incorrect instruction for use.
Context
GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Other recent recalls of similar products include Edwards EVOQUE Tricuspid Delivery System Recall (March 27, 2026), Philips Allura Xper FD10C Medical System Recall (Dec. 15, 2025), and Philips Allura Xper FD10F Medical System Recall (Dec. 15, 2025).
How to tell if you have this one
Check for serial numbers CU4.0-01438 through CU4.0-02026 or GTIN 00858593006462 on the console. The product is part of the EkoSonic Endovascular System.
Brand
Boston Scientific
Product
EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Boston Scientific
Reach out to Boston Scientific for specific guidance on the recalled units and next steps.
Where it went and when
Where it was distributed
Distributed in 7 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Distribution was made to CA, IL, KY, OH, OK, RI, TX. There was no government/military distribution. Foreign distribution was made to Chile and Hong Kong.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Illinois, Kentucky, Ohio, Oklahoma, Rhode Island, Texas.
Recall timeline
FDA published this recall 27 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0149-2023 (October 13, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0149-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.