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Azurion System (Philips) – power supply issue (2025)

Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.

Moderate

FDAAug 1, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Ojasvita Chocomalt (Sri Sri Tattva) – Undeclared Soy (2025)

Undeclared Soy

Product contains undeclared soy lecithin.

Class IIModerate

FDAAug 1, 2025CA, GA, IL +7 more• SRI SRI TATTVA

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Azurion System (Philips) – power supply issue (2025)

Ojasvita Chocomalt (Sri Sri Tattva) – Undeclared Soy (2025)

Allura System (Philips) – power supply issue (2025)

Allura Xper X-Ray System (Philips) – component missing (2025)

7up Zero Sugar Tropical Soda (Buffalo Rock) – mislabeled product (2025)

ACUSON AcuNav Ultrasound Catheter (Unknown) – particulate risk (2025)

ViewFlex Xtra ICE Catheter (Unknown) – particulate risk (2025)

Inquiry Steerable Diagnostics Catheter (Unknown) – particulate risk (2025)

Livewire Steerable Electrophysiology Catheter (Unknown) – particulate risk (2025)

Frozen Oyster Meat (Jayone Foods) – Norovirus Contamination (2025)

Frozen Oyster Meat (Jayone Foods) – norovirus contamination (2025)

Webster CS Catheter (Unknown) – particulate risk (2025)

LinkSymphoKnee System (Waldemar Link) – screw issue (2025)

Sterile Cover Kit (Lumicell) – elastic band failure (2025)

Sodium Bicarbonate Injection (Exela Pharma) – Arsenic Impurities (2025)

RECOMBINATE Antihemophilic Factor (Cardinal Health) – Temperature Deviation (2025)

Epikut Plus Dental Implant (S.I.N. Implant) – storage conditions (2025)

Xolair Injection (Cardinal Health) - Temperature Exposure (2025)

Fortress Introducer Sheath (Contract Medical) – labeling error (2025)

Clearview Strep A Kit (Mckesson) – classification error (2025)