CLASS II ONGOING Device recall · Reported 19 Nov 2025 · FDA Enforcement Report
Affinity NT Oxygenator, Oxygenator recalled
Medtronic Perfusion Systems is recalling Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous, distributed in Arizona, California, Tennessee. The recall was initiated on 12 Sep 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0487-2026
- FDA event ID
- 97702
- Recalling firm
- Medtronic Perfusion Systems, Brooklyn Park, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Sep 2025
- FDA classified
- 10 Nov 2025
- Reported
- 19 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 12 Sep 2025 | Recall initiated by company | |
| 10 Nov 2025 | Classified by FDA | +59 days |
| 19 Nov 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
Product as listed by the FDA
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Where it was distributed
US States: AZ, CA, TN
Questions about this recall
Why was it recalled?
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
Which lots are affected?
Lot Number: 231621003; Unit Serial Number: 5117755016; UDI-DI: 00763000187842, 20763000187846
Where was it sold?
US States: AZ, CA, TN
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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