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DiamondTOUCH Inflation Device (Merit Medical) – Sterile Barrier Breach (2024)

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

FDAAug 19, 2024Nationwide• Merit Medical Systems, Inc.

Ground Cinnamon (Gutierrez Distributors) – Elevated Lead (2024)

Elevated lead levels in cinnamon

Class IIModerate

FDAAug 16, 2024IN, NY• Gutierrez Distributors, LLC

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DiamondTOUCH Inflation Device (Merit Medical) – Sterile Barrier Breach (2024)

Ground Cinnamon (Gutierrez Distributors) – Elevated Lead (2024)

Creatine Kinase Assay (Roche) - Calibration Abnormality (2024)

Vios Monitoring System (Murata Vios) - Battery Depletion Risk (2024)

Dailies Total1 Contacts (Alcon) - Quality Material Issue (2024)

Airvo 3 Respiratory Device (Fisher & Paykel) - High Pressure Oxygen Risk (2024)

FilmArray 2.0 Instrument (BioFire) - Calibration Equipment Problem (2024)

FilmArray Torch Module (BioFire) - Calibration Equipment Problem (2024)

Monarch Platform Urology (Auris Health) – Electrical Short Risk (2024)

Monarch Platform Endoscopy (Auris Health) – Electrical Short Risk (2024)

BD Phoenix M50 (Becton Dickinson) – E. Coli Misidentification (2024)

BD Phoenix 100 (Becton Dickinson) – E. Coli Misidentification (2024)

Inspire Model 4063 Stimulation Lead (Inspire) – Labeling Error (2024)

MiniMed 630G (Medtronic) – Physical Impact Damage (2024)

MiniMed 670G (Medtronic) – Physical Impact Damage (2024)

MiniMed 620G (Medtronic) – Physical Impact Damage (2024)

Inspire Model 4340 Respiratory Sensing Lead (Inspire) – Labeling Error (2024)

FreeStyle Libre 3 Sensors, REF: 72081-01, component of th... (Abbott Diabetes Care, Inc.) – laceration hazard (2024)

Ciprofloxacin Ophthalmic Solution (FDC) – Defective Container (2024)

ClotTriever XL Catheter, 30 mm, REF: 41-102, used with In... (Inari Medical Oak Canyon) – laceration hazard (2024)