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CX Preconnect TENACIO Pump (Boston Scientific) – Inflation Issue (2025)

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

FDASep 11, 2025Nationwide• Boston Scientific Corporation

Olympus EVIS EXERA Bronchovideoscope (Olympus) – Usage Guidance Update (2025)

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

Moderate

FDASep 11, 2025Nationwide• Olympus Corporation of the Americas

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CX Preconnect TENACIO Pump (Boston Scientific) – Inflation Issue (2025)

Olympus EVIS EXERA Bronchovideoscope (Olympus) – Usage Guidance Update (2025)

Olympus EVIS EXERA III Bronchovideoscope (Olympus) – Usage Guidance Update (2025)

TENACIO Pump with InhibiZone (Boston Scientific) – Inflation Problem (2025)

LGX Preconnect TENACIO Pump (Boston Scientific) – Inflation Problem (2025)

BD Alaris Pump Infusion Sets (CareFusion) – Performance Range Problem (2025)

CXR Preconnect TENACIO Pump (Boston Scientific) – Inflation Issue (2025)

TENACIO Pump without InhibiZone (Boston Scientific) – Inflation Issue (2025)

Olympus Bronchofiberscope BF 1T60 (Olympus) – Usage Guidance Update (2025)

ECHELON Linear Cutters (Ethicon) – Unsterilized Devices (2025)

Olympus Bronchofiberscope BF PE2 (Olympus) – Usage Guidance Update (2025)

Olympus Bronchovideoscope BF-Q170 (Olympus) – Usage Guidance Update (2025)

Ferno Power X2 Ambulance Cot (Ferno) – Fastening Post Defect (2025)

Sodium Chloride Injection (Excelsior) – Concentration Deviation (2025)

Omnipod 5 iOS App (Unknown) – Manual Entry Magnification Issue (2025)

iNSitu Bipolar Hip System (Theken) – Sterile Barrier Risk (2025)

Olympus Bronchovideoscope BF-1TH1100 (Olympus) – Usage Guidance Update (2025)

Medline Anesthesia Set (Medline) – IV Set Leakage (2025)

TactiFlex Ablation Catheter (Abbott) – Tip Detachment Risk (2025)

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