Devices

Name Classification Manufacturer Risk Class Country Source
Arrowgard Blue Two Lumen CVC Super Kit General Hospital and Personal Use Devices Arrow International Inc 2 United States
NOVAPLUS General and Plastic Surgery Devices 3M Company / Medical Division 2 United States
Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm). Gastroenterology-Urology Devices Datascope Corp 2 United States
Remel Chocolate Agar Immunology and Microbiology Devices Remel, Inc. 1 United States
HealthPax (HP1). Cranial Electrotherapy Stimulator GZJ Neurological Devices Health Directions, Inc 3 United States
SOLO-care Plus with Aqualube, Multi-purpose solution*** AquaSoft (Private label), Multi-purpose solution***Sterile***For soft lenses Ophthalmic Devices Ciba Vision Corporation 2 United States
IR 1200 Insulin Pump General Hospital and Personal Use Devices Animas Corporation 2 United States
SOMATOM Emotion Duo XRay Radiology Devices Siemens Medical Solutions USA, Inc 2 United States
SOMATOM Emotion Duo XRay Radiology Devices Siemens Medical Solutions USA, Inc 2 United States
SOMATOM Sensation 16 Radiology Devices Siemens Medical Solutions USA, Inc 2 United States
Tosoh Immunology and Microbiology Devices Tosoh Bioscience, Inc. 2 United States
Device Recall Buprenorphine Test Card LumiQuick Diagnostics Inc. United States
Difco (TM) BBL (TM) Gram Crystal Violet Hematology and Pathology Devices Becton Dickinson & Co. 1 United States
SOMATOM Sensation 16 ( Straton) Radiology Devices Siemens Medical Solutions USA, Inc 2 United States
SOMATOM Sensation Cardiac Radiology Devices Siemens Medical Solutions USA, Inc 2 United States
SOMATOM Sensation Cardiac ( Straton) Radiology Devices Siemens Medical Solutions USA, Inc 2 United States
SOMATOM Sensation 10 Radiology Devices Siemens Medical Solutions USA, Inc 2 United States
Leonard MMWS Radiology Devices Siemens Medical Solutions USA, Inc 2 United States
Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1. Radiology Devices Fujifilm Medical System USA, Inc. 2 United States
CLARION 1.2, Advanced Bionics implantable cochlear stimulator Ear, Nose, and Throat Devices Advanced Bionics 3 United States
CLARION CII, Advanced Bionics implantable cochlear stimulator Ear, Nose, and Throat Devices Advanced Bionics 3 United States
HiRes 90, Model CI140001, Advanced Bionics implantable cochlear stimulator Ear, Nose, and Throat Devices Advanced Bionics 3 United States
Proven Porous CR Femur Orthopedic Devices Stelkast Co 2 United States
Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Model 801763. Cardiovascular Devices Terumo Cardiovascular Systems Corp 2 United States
Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764. Cardiovascular Devices Terumo Cardiovascular Systems Corp 2 United States