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Wayson Hydrocolloid (Medline) – Sterility Compromise (2025)

There is a potential for the sterility of the device to be compromised.

FDAFeb 19, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

Merge Cardio (Merge Healthcare) – Measurement Workflow Issue (2025)

When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.

Moderate

FDAFeb 19, 2025Nationwide• Merge Healthcare, Inc.

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Wayson Hydrocolloid (Medline) – Sterility Compromise (2025)

Merge Cardio (Merge Healthcare) – Measurement Workflow Issue (2025)

Genesis GV70 Electrified (Genesis) – Software Problem (2025)

Calais Grape Jelly (Elwood) – Undeclared Colors (2025)

Revolution CT System (GE Medical) – Potential System Issue (2025)

BD Care Coordination Engine (CareFusion) – Programming Request Issue (2025)

Revolution CT ES System (GE Medical) – Potential System Issue (2025)

BD Alaris Systems Manager (CareFusion) – Programming Request Issue (2025)

Revolution Apex CT System (GE Medical) – Potential System Issue (2025)

Volvo VNL (Volvo) – Brake Activation Delay (2025)

Choshiya Rakkyo Zuke Vegetables – Refrigeration Warning (2025)

Avastin Intravitreal Injection (Turbare) – Sterility Concern (2025)

Fukushin Zuke Prepared Mix Vegetables (AKT Trading) – Refrigeration Labeling (2025)

Dried Longan Pulp (Growland) – Elevated Sulfite Levels (2025)

Choshiya Shiba Zuke Vegetables – Refrigeration Warning (2025)

Menma Ajitsuke Bamboo Shoots (AKT Trading) – Refrigeration Labeling (2025)

Soft Tsubozuke Prepared Mix Vegetables (AKT Trading) – Refrigeration Labeling (2025)

Aokappa Zuke Prepared Mix Vegetables (AKT Trading) – Refrigeration Labeling (2025)

Introcan Safety 3 IV Catheter (B Braun) – Valve Housing Risk (2025)

Daye Heavy Flow Refill (Daye) – 510(k) Clearance Missing (2025)