Terumo Cardiovascular Systems Corporation: Medical Device Recall in 2019 - (Recall #: Z-2101-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE

Product Classification:

Class II

Date Initiated: June 14, 2019

Date Posted: August 7, 2019

Recall Number: Z-2101-2019

Event ID: 83240

Reason for Recall:

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

Status: Terminated

Product Quantity: 16 units

Code Information:

Lot Number: WP17

Distribution Pattern:

MI Foreign: Japan, Belgium

Voluntary or Mandated:

Voluntary: Firm initiated