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Draeger Globe-Trotter and Globe-Trotter IC, Model numbers... (Draeger Medical Systems, Inc.) – the firm has initiated this recall to... (2022)

The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the working pressure of the system.

FDAMay 20, 2022DE, IN• Draeger Medical Systems, Inc.

PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .03... (Cordis US Corp) – potential for stent dislodgement and ... (2022)

Potential for stent dislodgement and associated failures related to two specific sizes of the device.

FDAMay 20, 2022Nationwide• Cordis US Corp

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Draeger Globe-Trotter and Globe-Trotter IC, Model numbers... (Draeger Medical Systems, Inc.) – the firm has initiated this recall to... (2022)

PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .03... (Cordis US Corp) – potential for stent dislodgement and ... (2022)

Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), ... (Agilent Technologies, Inc.) – label provided for substrate vail con... (2022)

CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD in... (Menarini Silicon Biosystems) – high number of total images/unassigne... (2022)

Sensica Urine Output System (C.R. Bard Inc) – complaints relating to urine output m... (2022)

ABL800 Flex Analyzer (Radiometer) – Potential Bias (2022)

Modular Cathcart Fracture Hip Ball (DePuy) – Offset Discrepancy (2022)

Baby Gorilla Plating System (Paragon 28) – Incorrect Labeling (2022)

VSP Reconstruction (Medical Modeling) – Design Issue (2022)

MAC F/O Laryngoscope (Baxter) – Packaging Error (2022)

Drager SafeStar 55 (Draeger) – Filter Occlusion (2022)

RayOne IOL (Rayner) – Mislabeled Package (2022)

Volcano Visions IVUS Catheter (Volcano) – IFU Omission (2022)

EEA Circular Stapler (Unknown) – Staple Guide Risk (2022)

NeuMoDx Flu Test Strip (NeuMoDx) – Sensitivity Reduction (2022)

Medline Pill Splitters (Medline) – Blade Exposure (2022)

Vygon Dressing Kit (Stradis) – Seal Incompleteness (2022)

CARESCAPE Central Station (GE Healthcare) – Power Supply Failure (2022)

BD Connecta Plus3 White (Becton Dickinson) – Leakage Risk (2022)

BD Connecta Plus1 360 (Becton Dickinson) – Leakage Risk (2022)