Lower riskMedical device recall · FDA · Published September 12, 2025
Medtronic Affinity NT Oxygenator Recall: Decreased CO2 Transfer Risk
Medtronic recalls Affinity NT Oxygenators with decreased CO2 gas transfer rates that may not meet performance requirements. Affected units have specific product numbers and serial codes.
“Medtronic Affinity NT Oxygenator Recall: Decreased CO2 Transfer Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51294-medtronic-affinity-nt-oxygenator-recall-decreased-co2-transfer-risk. Based on FDA recall #Z-0487-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0487-2026%22&limit=1).
The FDA announced on September 12, 2025, that Medtronic Perfusion Systems is recalling Affinity NT Oxygenator and related products due to decreased CO2 gas transfer rates. The recall affects 26 units distributed in Arizona, California, and Tennessee.
How to tell if you have it
Brand: Medtronic Perfusion Systems
Product: Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir
Product Number: 541B
Lot Number: 231621003
Unit Serial Number: 5117755016
UDI-DI: 00763000187842, 20763000187846
The hazard
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
Context
GovInfoNow's records show Medtronic Perfusion Systems has 31 other recalls on record since June 22, 2017. Other recent recalls of similar products include Medline Oxygen Masks Recall (November 21, 2025), Baxter Blue Ventilator Adapter Module Recall (February 18, 2026), and Ventec V+Pro Ventilator Recall (March 25, 2026).
How to tell if you have this one
Check for Product Number 541B, Lot Number 231621003, or Unit Serial Number 5117755016 on the device. The UDI-DI codes 00763000187842 and 20763000187846 also identify affected units.
Brand
Medtronic Perfusion Systems
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Details
Look for Product Number 541B, Lot Number 231621003, or Unit Serial Number 5117755016 on the device.
Where it went and when
Where it was distributed
Distributed in 3 states.
Listed by the agency
Not listed
FDA distribution: “US States: AZ, CA, TN” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Tennessee.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-0487-2026 (September 12, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0487-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.