Medtronic Perfusion Systems recalls Affinity NT Oxygenator
- Recalling company
- Medtronic Perfusion Systems
- Product
- Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
- Reason
- Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Sep 12, 2025
- Reported
- Nov 19, 2025
- Distribution
- US States: AZ, CA, TN
- Status
- Ongoing
- Quantity
- 26 units
- Lot / codes
- Lot Number: 231621003; Unit Serial Number: 5117755016; UDI-DI: 00763000187842, 20763000187846
- Company location
- Brooklyn Park, MN
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0487-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0487-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.