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Olympus OER-Mini (Aizu Olympus) – Maintenance Warning (2025)

Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

Low

FDAOct 31, 2025Nationwide• Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan

IntelliVue Patient Monitor MX500 (Philips) – Alarm Failure Risk (2025)

Potential issue where the IntelliVue monitors did not alarm.

High

FDAOct 31, 2025Nationwide• Philips North America Llc

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Olympus OER-Mini (Aizu Olympus) – Maintenance Warning (2025)

IntelliVue Patient Monitor MX500 (Philips) – Alarm Failure Risk (2025)

Monarch Kratom Green Maeng Da (Lotus Vaping) – Salmonella Risk (2025)

Monarch Kratom Red Bali (Lotus Vaping) – Salmonella Risk (2025)

Artisan English Muffins (Blue Oven) – Undeclared Milk (2025)

Xpert BCR-ABL Ultra (Cepheid) – Test Result Inaccuracy (2025)

FlexLab FLX-217-40 (Inpeco) – Labeling Mismatch Risk (2025)

Monarch Kratom Bali Gold Powder – Salmonella Risk (2025)

Monarch Kratom White Elephant Powder – Salmonella Risk (2025)

Single Use Ligating Device (Olympus) – Loop Detachment Issue (2025)

FlexLab FLX-217-10 (Inpeco) – Labeling Mismatch Risk (2025)

DTT Respiratory Specimen (Copan) – Reagent Functionality Issue (2025)

Infusomat Set (B Braun) – Medication Backflow Risk (2025)

Burette Set (B Braun) – Medication Backflow Risk (2025)

IV Administration Set (B Braun) – Medication Backflow Risk (2025)

CARESAFE Set (B Braun) – Medication Backflow Risk (2025)

Vista Set (B Braun) – Medication Backflow Risk (2025)

RATE FLOW Set (B Braun) – Medication Backflow Risk (2025)

Incisive CT (Philips) – Scanner Component Detachment (2025)

ADDitIV Set (B Braun) – Medication Backflow Risk (2025)