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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

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

High number of total images/unassigned events including (dual positives) and the potential for false positive results being placed into the image gallery in some patient samples

FDAMay 20, 2022CA, FL, IL +9 more• Menarini Silicon Biosystems

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

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

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

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

Artis Icono, Interventional Fluoroscopic X-Ray System, Mo... (Siemens Medical Solutions USA, Inc) – during system tests, an increased wea... (2022)

EIT CIF cage, H 6mm, 8degree, L- an intervertebral body f... (DePuy Spine, Inc.) – label on the outer carton does not ma... (2022)

EIT CIF cage, H 7mm, 8degree, S- an intervertebral body f... (DePuy Spine, Inc.) – label on the outer carton does not ma... (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)

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

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

AMBI Skincare Exfoliating Wash (Family Dollar) – temperature storage issue (2022)

AMBI Skincare Facial Moisturizer (Family Dollar) – temperature storage issue (2022)

Luxury Hygiene Hand Sanitizer 8 FL OZ (Family Dollar) – temperature storage issue (2022)

Luxury Hygiene Hand Sanitizer (Family Dollar) – temperature storage issue (2022)

AMBI Skincare Fade Cream Oily Skin (Family Dollar) – temperature storage issue (2022)

AMBI Skincare Fade Cream Normal Skin (Family Dollar) – temperature storage issue (2022)

Aveeno Daily Moisturizing Lotion (Family Dollar) – temperature storage issue (2022)