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

Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq

Class IHigh

FDAFeb 13, 2025Nationwide• ICU Medical, Inc.

Mineral Sunscreen (Babyganics) – Chemical Contamination (2025)

Chemical Contamination

Class IIModerate

FDAFeb 13, 2025Nationwide• Johnson, S C and Son, Inc

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

Mineral Sunscreen (Babyganics) – Chemical Contamination (2025)

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

Nelarabine Injection (Zydus) – Impurity Specifications (2025)

T4E TR50 Air Pistols (Unknown) – Impact Injury (2025)

6-in-1 Pounding Games – Ingestion Hazard (2025)

Land Rover Range Rover Evoque (Land Rover) – Right Knee Airbag Cover (2025)

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

Youth Solitude Jackets – Strangulation Risk (2025)

LoGest Climbing Ropes (Unknown) – Fall Danger (2025)

Mopar Center Stack Displays (Mopar) – Display Problem (2025)

Powerheart G5 AED (ZOLL) – device self-test failure (2025)

SHEIN Kids' Pajama Sets (SHEIN) – Burn Hazard (2025)

Land Rover Range Rover Evoque (Land Rover) – Left Knee Airbag Cover (2025)

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

ProPort Venous Access System (Smiths Medical) – Port Housing Separation (2025)

ProPort Plastic Venous System (Smiths Medical) – port housing separation (2025)

Remel Blood Agar Plate (Remel) – Listeria Contamination (2025)

Igloo 90 Qt. Rolling Coolers (Igloo) – Amputation Hazard (2025)

GMC Savana (GMC) – Door Impact Beam Issue (2025)