Z-0487-2026 Class II Ongoing
FDA device recall Z-0487-2026 was initiated by Medtronic Perfusion Systems on September 12, 2025 and is designated Class II. Reason for recall: Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements. The recall status is ongoing. Affected quantity: 26 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 19, 2025
- Initiation Date
- September 12, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26 units
Product Description
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Reason for Recall
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
Distribution Pattern
US States: AZ, CA, TN
Code Information
Lot Number: 231621003; Unit Serial Number: 5117755016; UDI-DI: 00763000187842, 20763000187846