# FDA recall Z-0565-2021

> **Terumo Cardiovascular Systems Corporation** · Class II · device recall initiated 2020-11-11.

## Product

(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC   modified to Advance, Sterile  Catalog Number: 3CX*FX25RWC    (2) Capiox FX25 (East) Advance Oxygenator - FX25 with right port, 4-liter Reservoir, XC   modified to Advance  Catalog Number: 3CX*FX25REC    CAPIOX FX25 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir-intended to be used to exchange gases between blood and a gaseous environment during cardiopulmonary bypass surgery.

## Reason for recall

Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West)

## Distribution

US Nationwide  Foreign: Belgium, India

## Key facts

- **Recall number:** Z-0565-2021
- **Recalling firm:** Terumo Cardiovascular Systems Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-11
- **Report date:** 2020-12-23
- **Termination date:** 2021-11-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ann Arbor, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0565-2021

## Citation

> AI Analytics. FDA recall Z-0565-2021. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0565-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*