Terumo recalls Capiox FX25 Advance Oxygenators with incorrect East/West configuration for heart surgery. This may cause improper gas exchange during cardiopulmonary bypass. Affected units have specific catalog numbers and lot numbers.
“Terumo Capiox FX25 Oxygenator Recall: Incorrect Configuration Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63931-terumo-capiox-fx25-oxygenator-recall-incorrect-configuration-risk. Based on FDA recall #Z-0565-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0565-2021%22&limit=1).
The FDA announced on Nov. 11, 2020, that Terumo Cardiovascular Systems Corporation voluntarily recalled Capiox FX25 Advance Oxygenators due to incorrect configuration risks. The agency issued recall number Z-0565-2021 for the Class II device.
How to tell if you have it
Brand: Terumo
Product: Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog
Catalog Number: 3CX*FX25RWC
Lot Number: YD16
UPC: 00699753450837
Product: Capiox FX25 (East) Advance Oxygenator - FX25 with right port, 4-liter Reservoir, XC modified to Advance
Catalog Number: 3CX*FX25REC
Lot Number: YD23
Unit GTIN Code: (01)00699753450837
The hazard
The Capiox FX25 Advance Oxygenator may be the incorrect configuration, specifically confusing East versus West orientations. The device is intended to exchange gases between blood and a gaseous environment during cardiopulmonary bypass surgery.
Context
GovInfoNow's records show Terumo Cardiovascular Systems Corporation has 20 other recalls on record since June 27, 2017. Other recent recalls of similar products include Medtronic Octopus Evolution AS Tissue Stabilizer Model TS2500 Recall (May 12, 2026), Ventec V+Pro Ventilator Recall (March 25, 2026), and Baxter Blue Ventilator Adapter Module Recall (Feb. 18, 2026).
How to tell if you have this one
Check for catalog numbers: 3CX*FX25RWC (West) or 3CX*FX25REC (East). Also look for lot numbers YD16 or YD23. These units are intended for heart surgery procedures.
Brand
Terumo
Product
(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the catalog number and lot number to confirm if your unit is affected. The affected units have specific catalog numbers and lot numbers.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “US Nationwide Foreign: Belgium, India” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0565-2021 (November 11, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0565-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.