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Olympus Ultrasound Needle (Olympus) – Needle Angle Nonconformance (2023)

Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.

Moderate

FDAMar 31, 2023Nationwide• Olympus Corporation of the Americas

Eye and Ear Dropper (Apothecary) – Glass Particulate Concern (2023)

Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb.

Moderate

FDAMar 30, 2023Nationwide• Apothecary Products, LLC

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Olympus Ultrasound Needle (Olympus) – Needle Angle Nonconformance (2023)

Eye and Ear Dropper (Apothecary) – Glass Particulate Concern (2023)

Medicine Dropper (Apothecary) – Glass Particulate Risk (2023)

Binx io CT/NG Assay (Binx Health) – Performance Detection Issue (2023)

Laryngeal Mask Airway Pack (Medline) – Labeling Problem (2023)

YelloPort Elite Trocar (Surgical Innovations) – Sterility Risk (2023)

Centricity PACS-IW (GE Healthcare) – Patient Info Risk (2023)

YelloPort Elite Trocar (Surgical Innovations) – Sterility Concern (2023)

Distal Phasitron (Percussionaire) – Breathing Circuit Issue (2023)

Centricity Universal Viewer (GE Healthcare) – Patient Data Issue (2023)

Centricity PACS-IW (GE Healthcare) – Patient Information Mismatch (2023)

JOURNEY II UNI Tibia Insert (Smith & Nephew) – mispack error (2023)

TDHisto/Cyto Software (Technidata) – incorrect label info (2023)

Omnicell IVX Station (OmniCell) – dose accuracy risk (2023)

GEM NEUROTUBE (Baxter) – brittle mesh tube (2023)

Flexible Grasping Forceps (Richard Wolf) – potential jaw malfunction (2023)

Flexible Biopsy Forceps (Richard Wolf) – potential jaw malfunction (2023)

Flexible Grasping Forceps (Richard Wolf) – potential jaw malfunction (2023)

Shiley Tracheostomy Tube (Covidien) – connector diameter issue (2023)

ANGIOGUARD Guidewire System (Cordis) – potential separation risk (2023)