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Olympus OER-Elite (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 MX100 (Philips) – monitoring alarm issue (2025)

Potential issue where the IntelliVue monitors did not alarm.

High

FDAOct 31, 2025Nationwide• Philips North America Llc

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

IntelliVue Patient Monitor MX100 (Philips) – monitoring alarm issue (2025)

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

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

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

NICO BrainPath (Stryker) – latex packaging issue (2025)

IntelliVue Multi Measurement Server X2 (Philips) – monitoring alarm issue (2025)

IntelliVue MP80 (Philips) – monitoring alarm issue (2025)

Stryker MV3 Bariatric Bed (Stryker) – Proximity Concern (2025)

NICO Myriad Illumination Pack (Stryker) – Latex Contamination Risk (2025)

IntelliVue MP20 (Philips) – Alarm Failure Risk (2025)

Lidocaine HCI with Epinephrine (Novocol) – cracked cartridges (2025)

OraVerse Injection (Novocol) - Defective Container (2025)

Marinara Sauce (First & Last Tavern) – Botulinum Risk (2025)

Organic Moringa Powder (BULK & ORGANIC) – Salmonella Contamination (2025)

Phytonadione Injectable Emulsion (Cipla) – stability failure (2025)

Wecare Enema (Blossom) – cGMP deviation (2025)

Mepivacaine Injection (Novocol) – cracked cartridges (2025)

WeCare Zinc Oxide Ointment (Blossom) – cGMP deviation (2025)

Nivagen Zinc Oxide Ointment (Blossom) – cGMP deviation (2025)