The Recall Desk

FDA (Devices) recall action 86649

Olympus Corporation of the Americas recalled 10 products on 2020-12-09

The FDA (Devices) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.

Products
10
Announced
2020-12-09
Critical
0
Units
8,522

Why these products were recalled

A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–10 of 10

  • HighFDA (Devices)··2020-12-09

    Olympus Ultrasound Endoscope Recall for Updated Cleaning Instructions

    Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.

    Product
    Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-12-09

    Olympus Ultrasound Endoscope Recall for Updated Cleaning Instructions

    Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.

    Product
    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.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-12-09

    Olympus Ultrasound Endoscope Recall for Updated Cleaning Instructions

    Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.

    Product
    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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-12-09

    Olympus Ultrasound Endoscope Recall for Infection Risk Mitigation

    Olympus is recalling ultrasound endoscopes to reduce the risk of patient infections by adding a new inspection step to the cleaning and disinfection instructions.

    Product
    Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-12-09

    Olympus Ultrasound Endoscope Recall for Infection Risk Reduction

    Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.

    Product
    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.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-12-09

    Olympus Ultrasound Endoscope Recall for Updated Cleaning Instructions

    Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.

    Product
    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.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-12-09

    Olympus Ultrasound Endoscope Recall for Updated Cleaning Instructions

    Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.

    Product
    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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-12-09

    Olympus Ultrasound Endoscope Recall for Updated Cleaning Instructions

    Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.

    Product
    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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-12-09

    Olympus Ultrasound Endoscope Recall for Infection Risk Mitigation

    Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.

    Product
    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.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-12-09

    Olympus Ultrasound Endoscope Recall for Infection Risk

    Olympus is recalling ultrasound endoscopes to reduce the risk of patient infections by adding a new inspection step to the cleaning instructions.

    Product
    Olympus Ultrasound Endoscope, Model number: GF-UM160 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
    Category
    Distribution
    0 states