FDAFDA · Food and drugs·Recall number Z-0487-2026
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Published November 19, 2025 · Recall initiated: September 12, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Perfusion Systems
- Distributor
- US States: AZ, CA, TN
- Lot
- Lot Number: 231621003; Unit Serial Number: 5117755016; UDI-DI: 00763000187842, 20763000187846
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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