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IntelliVue Patient Monitor (Philips) – alarm failure (2025)

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

High

FDAJan 15, 2025FL, NC• Philips North America Llc

Single Use Guide Sheath Kit (Olympus) – radiopaque tip risk (2025)

Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.

High

FDAJan 15, 2025Nationwide• Olympus Corporation of the Americas

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IntelliVue Patient Monitor (Philips) – alarm failure (2025)

Single Use Guide Sheath Kit (Olympus) – radiopaque tip risk (2025)

Bacon Popcorn Seasoning (TS Food Packaging) – Undeclared Soy (2025)

Marionberry Jelly Sticks Milk (Candy Basket) – Undeclared Additives (2025)

Marionberry Jelly Sticks Dark (Candy Basket) – Undeclared Additives (2025)

Lemon Jelly Sticks WHITE (The Candy Basket) – Undeclared Additives (2025)

Lemon Jelly Sticks DARK (The Candy Basket) – Undeclared Additives (2025)

Menma Ajitsuke Bamboo Shoots (AKT Trading) – Storage Mislabeling (2025)

Monkfish Liver (Mutual Trading) – Undeclared Milk (2025)

Raspberry Jelly Sticks MILK (The Candy Basket) – Undeclared Additives (2025)

Orange Jelly Sticks (Candy Basket) – Undeclared Additives (2025)

Orange Jelly Sticks DARK (The Candy Basket) – Undeclared Additives (2025)

Raspberry Jelly Sticks DARK (The Candy Basket) – Undeclared Additives (2025)

Infinity Central Station (Draeger) – Speaker Malfunction (2025)

Pancake & Waffle Mix (Pearl Milling) – Undeclared Milk (2025)

Valentine's Cookie Dough (Nestle) – Improper Storage (2025)

Allura CV20 (Philips) – Safety Issue (2025)

Azurion 7 M20 (Philips) – Patient Fall Risk (2025)

Azurion 5 M20 (Philips) – Safety Issue (2025)

Allura Xper FD20/10 (Philips) – Patient Fall Risk (2025)