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Atlan A350 (Draeger) – Mechanical Ventilation Failure (2025)

The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

Moderate

FDASep 9, 2025AL, AZ, CA +23 more• Draeger, Inc.

BioPro Femoral Head (BioPro) – Sterile Packaging Issue (2025)

Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

Low

FDASep 9, 2025MI, TX• BioPro, Inc.

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Atlan A350 (Draeger) – Mechanical Ventilation Failure (2025)

BioPro Femoral Head (BioPro) – Sterile Packaging Issue (2025)

NOxBOXi Nitric Oxide System (NOXBOX) – Internal Fault Risk (2025)

Ashvins HEYEX 2 (MedicalCommunications) – Measurement Inaccuracy (2025)

BioPro Endo Head (BioPro) – Sterile Packaging Issue (2025)

BioPro Endo Head (Ceramic) (BioPro) – Sterile Packaging Issue (2025)

BioPro Femoral Head (BioPro) – Sterile Packaging Issue (2025)

NOxBOXi Nitric Oxide System (NOXBOX) – Flow Sensor Fluctuations (2025)

BioPro Femoral Head (BioPro) – Sterile Packaging Issue (2025)

BioPro Bipolar Head (BioPro) – Sterile Packaging Issue (2025)

ICU Medical Admin Set (ICU Medical) – Port Weld Leak (2025)

ICU Medical Oncology Kit (ICU Medical) – Port Weld Leak (2025)

ICU Medical Extension Set (ICU Medical) – Port Weld Leak (2025)

ICU Medical Double ChemoLock Syringe Set (ICU Medical) – Port Weld Leak (2025)

ICU Medical ChemoLock Vial Spike (ICU Medical) – Port Weld Leak (2025)

ICU Medical ChemosafeLock Bag Spike (ICU Medical) – Port Weld Leak (2025)

ICU Medical ChemoLock Bag Spike (ICU Medical) – Port Weld Leak (2025)

ICU Medical ChemosafeLock Vial Adapter (ICU Medical) – Port Weld Leak (2025)

ICU Medical ChemoLock Vial Spike (ICU Medical) – Port Weld Leak (2025)

ICU Medical ChemoLock Vial Spike (ICU Medical) – Port Weld Leak (2025)