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RefleXion X1 (Reflexion Medical) – Software Configuration Risk (2025)

Due to incorrect software configuration that potentially allows more than two (2) fractions within a 12-hour period (fractionLimits) and could potentially lead to adverse events (toxicity).

Moderate

FDAJul 22, 2025Nationwide• Reflexion Medical, Inc.

Bartels ELISA Legionella Test (Trinity Biotech) – Particulate Matter (2025)

Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.

Low

FDAJul 22, 2025Nationwide• Trinity Biotech USA

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RefleXion X1 (Reflexion Medical) – Software Configuration Risk (2025)

Bartels ELISA Legionella Test (Trinity Biotech) – Particulate Matter (2025)

LIFEPAK 1000 (Physio-Control) – Inspection Failure (2025)

LIFEPAK 15 (Physio-Control) – Inspection Failure (2025)

OtoLase Starter Kit (Lumenis) – Sterility Concern (2025)

LIFEPAK CR2 (Physio-Control) – Inspection Failure (2025)

Fresh Apple Bread (Hillside Orchard) – Undeclared Egg (2025)

BZK Antiseptic Towelette (Taizhou Kangping) – Sterility Issue (2025)

Cheese Bread (Hillside Orchard) – Undeclared Egg (2025)

Lorazepam Injection (Hikma) – Compound Impurities (2025)

Blueberry Fritter (Hillside Orchard) – Undeclared Egg (2025)

Fresh Peach Bread (Hillside Orchard) – Undeclared Egg (2025)

Banana Nut Bread (Hillside Orchard) – Undeclared Egg (2025)

Peach Fritter (Hillside Orchard) – Undeclared Egg (2025)

Fresh Blackberry Bread (Hillside Orchard) – Undeclared Egg (2025)

Cinnamon Pecan Bread (Hillside Orchard) – Undeclared Egg (2025)

Blueberry Bread (Hillside Orchard) – Undeclared Egg (2025)

Multigrain Bread (Breadbox) – Missing Sesame Allergen (2025)

Strawberry Bread (Hillside Orchard) – Undeclared Egg (2025)

Cinnamon Pecan Fritters (Hillside Orchard) – Undeclared Egg (2025)