Terumo Cardiovascular Systems Corporation: Medical Device Recall in 2023 - (Recall #: Z-1346-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE

Product Classification:

Class II

Date Initiated: March 1, 2023

Date Posted: April 12, 2023

Recall Number: Z-1346-2023

Event ID: 91775

Reason for Recall:

Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port.

Status: Ongoing

Product Quantity: 84 units

Code Information:

UDI-DI: (01)00699753450868; Lot Number AM03

Distribution Pattern:

US Nationwide. Belgium, Canada, Costa Rica, Thailand.

Voluntary or Mandated:

Voluntary: Firm initiated