Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Recalled by Terumo Cardiovascular Systems Corporation Due to Capiox NX19 Oxygenator may contain a non-functioning arterial...

Date: June 14, 2019
Company: Terumo Cardiovascular Systems Corporation
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Terumo Cardiovascular Systems Corporation directly.

Affected Products

Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market

Quantity: 123 units

Why Was This Recalled?

Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component

Where Was This Sold?

This product was distributed to 1 state: MI

Affected (1 state)Not affected

About Terumo Cardiovascular Systems Corporation

Terumo Cardiovascular Systems Corporation has 204 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report