(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter… — Class II medical device recall Z-0565-2021
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2020-12-23, distributed nationwide. Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West)
| Recall number | Z-0565-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Ann Arbor, MI, United States |
| Recall initiated | 2020-11-11 |
| Classified | 2020-12-14 |
| Reported by FDA | 2020-12-23 |
| Terminated | 2021-11-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, IN |
| UPC / GTIN / UDI-DI | 00699753450837 |
| Lot numbers | YD16, YD23 |
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)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0565-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.