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Portex Endotracheal Tube (Smiths Medical) – Diameter Inconsistency (2025)

Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.

Very High

FDAFeb 13, 2025Nationwide• Smiths Medical ASD, Inc.

Nelarabine Injection (Zydus) – Impurity Specifications (2025)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAFeb 13, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

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Portex Endotracheal Tube (Smiths Medical) – Diameter Inconsistency (2025)

Nelarabine Injection (Zydus) – Impurity Specifications (2025)

Potassium Chloride Injection (ICU Medical) – Labeling Error (2025)

Nelarabine Injection (Zydus) – Impurity Specifications (2025)

Potassium Chloride Injection (ICU Medical) – Labeling Error (2025)

Mineral Sunscreen (Babyganics) – Chemical Contamination (2025)

Mineral Sunscreen (Babyganics) – Chemical Contamination (2025)

Iodo Blanco Antiseptic (World Perfumes) – Container Defect (2025)

Proxima Surgical Drape (Medline) – Packaging Sterility Risk (2025)

Z1 Femoral Hip System (Zimmer) – stem inserter fracture (2025)

Zebra Thermal Printer (Remel) – fire hazard (2025)

Namic Convenience Kits (Medline) – luer fitting excess material (2025)

BD BBL TB Stain Kit (Becton Dickinson) – expiration mismatch (2025)

Chef's Line 3 Grain Burger (Fillo Factory) – Foreign Material (2025)

Alcohol Prep Pads (ViaMed) – Sterility Concerns (2025)

Chef's Line Black Bean Burger (Fillo Factory) – Foreign Material (2025)

Raisin Bran Muffins (JE Bakery) – Undeclared Walnuts (2025)

Good & Gather Green Beans (Del Monte) – Foreign Object (2025)

Noble Made Garlic Parmesan Wing Sauce (Spicin Foods) – Bottle Foaming (2025)

Chef's Line 3 Grain Slider (Fillo Factory) – Foreign Material (2025)