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Affinity NT Oxygenator (Medtronic) – Gas Transfer Defect (2025)

Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.

Low

FDASep 12, 2025AZ, CA, TN• Medtronic Perfusion Systems

Option ELITE Vena Cava Filter (Argon Medical) – Dilator Resistance (2025)

Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/or risk of venous intimal injuries if excessive force is applied

Moderate

FDASep 12, 2025Nationwide• Argon Medical Devices, Inc

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Affinity NT Oxygenator (Medtronic) – Gas Transfer Defect (2025)

Option ELITE Vena Cava Filter (Argon Medical) – Dilator Resistance (2025)

Orange EV E-Triever (Orange EV) – Hazard Light Failure (2023)

Ford Taurus (Ford) – Door Trim Detachment (2017)

Millenium MPS (GE Medical) – Service End Risk (2025)

STA Liatest D-Di (Diagnostica Stago) – D-Dimer Level Underestimation (2025)

Optima NX (GE Medical) – Service End Risk (2025)

Cardiac Workstation 5000 (Philips) – Power Module Failure (2025)

Elscint Model 4XX (GE Medical) – Service End Risk (2025)

Elscint Helix (GE Medical) – Service End Risk (2025)

Millenium Myosight (GE Medical) – Service End Risk (2025)

Elscint Varicam (GE Medical) – Service End Risk (2025)

Elscint Cardial (GE Medical) – Service End Risk (2025)

Starcam/Camstar (GE Medical) – Service End Risk (2025)

Shanghai United CT X-ray System (UIH) – Patient Table Interference (2025)

Ford Mustang (Ford) – Seat Belt Corrosion (2015)

Cardiac Workstation 7000 (Philips) – Power Module Failure (2025)

ChlorproMAZINE Hydrochloride Tablets (Major Pharmaceuticals) – N-Nitroso impurity (2025)

Espumil Foam Base (Letco Medical) – Labeling Problem (2025)

Skin MD Body Acne Cleanser (Private Label Skin Care) – benzene contamination (2025)