CLASS II Device recall · Reported 23 Dec 2020 · FDA Enforcement Report
Capiox (West) Advance Oxygenator- with left port Reservoir recalled
Terumo Cardiovascular Systems is recalling Capiox (West) Advance Oxygenator- with left port Reservoir, XC modified to Advance, distributed nationwide in the US. The recall was initiated on 11 Nov 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0565-2021
- FDA event ID
- 86779
- Recalling firm
- Terumo Cardiovascular Systems, Ann Arbor, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Nov 2020
- FDA classified
- 14 Dec 2020
- Reported
- 23 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 11 Nov 2020 | Recall initiated by company | |
| 14 Dec 2020 | Classified by FDA | +33 days |
| 23 Dec 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West)
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
(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.
Where it was distributed
US Nationwide Foreign: Belgium, India
Questions about this recall
Is Capiox (West) Advance Oxygenator- with left port Reservoir, XC modified to Advance recalled?
Yes. Terumo Cardiovascular Systems recalled Capiox (West) Advance Oxygenator- with left port Reservoir, XC modified to Advance on 11 Nov 2020. The recall is Class II and its status is Terminated. Recall number Z-0565-2021.
Why was it recalled?
Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West)
Which lots are affected?
(1) Lot Number: YD16 (2) Lot Number: YD23 Unit GTIN Code: (01)00699753450837
Where was it sold?
US Nationwide Foreign: Belgium, India
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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