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LOGIQ P10 Ultrasound (GE Medical) – Measurement Inaccuracy (2025)

The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.

Moderate

FDASep 18, 2025Nationwide• GE Medical Systems, LLC

Salem Sump PVC Tubes (Cardinal Health) – Valve Breakage Risk (2025)

Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.

Moderate

FDASep 18, 2025Nationwide• Cardinal Health 200, LLC

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LOGIQ P10 Ultrasound (GE Medical) – Measurement Inaccuracy (2025)

Salem Sump PVC Tubes (Cardinal Health) – Valve Breakage Risk (2025)

LOGIQ P10 HD Ultrasound (GE Medical) – Measurement Inaccuracy (2025)

Pain Management Tray (B Braun) – Catheter Connector Misalignment (2025)

PERIFIX Spinal Epidural Tray (B Braun) – Connector Position Problem (2025)

ESPOCAN Spinal Epidural Tray (B Braun) – Connector Position Problem (2025)

Airvo 2 (Fisher & Paykel) – Power Disconnection Risk (2025)

PERIFIX FX Epidural Tray (B Braun) – Connector Position Issue (2025)

Taproom Gourmet Fifth Avenue Mix (Egress) – Undeclared Allergens (2025)

Silver Horse Aluminium Milk Pan – Lead Contamination (2025)

Kirkland Signature Ahi Tuna Wasabi Poke – Listeria Contamination (2025)

Taproom Gourmet Park Mix (Egress) – Undeclared Allergens (2025)

Green Onions (Garden Fresh Foods) – Listeria Risk (2025)

Taproom Gourmet Empire Mix (Egress) – Undeclared Allergens (2025)

PERIFIX FX Epidural Tray (B Braun) – Catheter Connector Issue (2025)

Taproom Gourmet Broadway Mix (Egress) – Undeclared Allergens (2025)

Madison Mix (Taproom Gourmet) – Undeclared Allergens (2025)

MOSAIQ Oncology System (Elekta) – Care Plan Order Error (2025)

Azelaic Acid Gel (Glenmark) – Texture Complaint (2025)

Phasitron 5 IPV Valve (Percussionaire) – Leak and Usage Warning (2025)