# FDA recall Z-1346-2023

> **Terumo Cardiovascular Systems Corporation** · Class II · device recall initiated 2023-03-01.

## Product

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

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-1346-2023
- **Recalling firm:** Terumo Cardiovascular Systems Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-01
- **Report date:** 2023-04-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Elkton, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1346-2023

## Citation

> AI Analytics. FDA recall Z-1346-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1346-2023. Source: US FDA. Licensed CC0.

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