Olympus Corporation of the Americas: Medical Device Recalls in 2020

According to to data from the FDA, there were 18 medical device recalls made by Olympus Corporation of the Americas in 2020. See the details of the recalls below.

You can see similar recalls for other firms.

• ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.
• Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
• Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
• Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.
• Olympus Ultrasound Endoscope, Model number: GF-UE160-AL5 - Product Usage: used for endoscopic ultrasonic imaging of the gastrointestinal wall, bile and pancreatic ducts and surrounding organs.
• Olympus Ultrasound Endoscope, Model number :GF-UM20 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.
• Olympus Pleuravideoscope, Model LTF-160
• Olympus Pleuravideoscope, Model LTF-240
• Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
• Olympus Ultrasound Endoscope, Model number: GF-UM130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy accessories and other ancillary equipment for endoscopic ultrasound imaging of the gastrointestinal wall, biliary and pancreatic duct, and surrounding organs.
• Olympus Ultrasound Endoscope, Model Number: GF-UCT140-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.
• Olympus Ultrasound Endoscope, Model number: GF-UMQ130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy accessories and other ancillary equipment for endoscopic ultrasound imaging of the gastrointestinal wall, biliary and pancreatic duct, and surrounding organs.
• Olympus Ultrasound Endoscope, Model number: GF-UM160 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
• Olympus Ultrasound Endoscope, Model number: GF-UCT180 - Product Usage: used with an Olympus universal endoscopic ultrasound center or a diagnostic system (ALOKA CO. LTD), video system center, light source, documentation equipment, monitor, EndoTherapy accessories and other ancillary equipment.
• Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
• Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the biliary tract (common bile duct, cystic duct, and hepatic duct).
• Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial numbers - Product Usage: designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
• OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer