Medtronic Perfusion Systems 2025-11-19 Health serious FDA
Health · FDA · Recall #FDA-Z-0487-2026
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous… Recall
Issued November 19, 2025 · Medtronic Perfusion Systems
In November 2025, Medtronic Perfusion Systems recalled the Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
What you should do
- 1 Stop using Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Medtronic Perfusion Systems to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Medtronic Perfusion Systems
- Category
- Health
- Recall date
- November 19, 2025
- Units affected
- Not reported
- Sold at
- US States: AZ, CA, TN
- Recall number
- FDA-Z-0487-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Medtronic Perfusion Systems has 11 recalls in our database, including 2 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.