The Recall Desk

FDA (Devices) recall action 92633

Olympus Corporation of the Americas recalled 5 products on 2023-08-16

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2023-08-16
Critical
0
Units
7,667

Why these products were recalled

Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible

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.

1–5 of 5

  • HighFDA (Devices)··2023-08-16

    Olympus LF-P Tracheal Intubation Fiberscope Sterilization and Compatibility Update

    Olympus is updating labeling for 686 LF-P fiberscopes to clarify they are no longer compatible with OER reprocessors and specify new 100% ETO sterilization protocol.

    Product
    Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display monitor and other ancillary equipment for management of Endotracheal Tube
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-08-16

    Olympus Endoscope Reprocessor Labeling Revised for Compatibility and Sterilization Parameters

    Olympus is revising labeling for its OER-Elite, OER-Pro, and OER-Mini endoscope reprocessors due to incompatible endoscope models and incorrect sterilization parameters in previous labeling. The revisions remove two endoscope models from the compatibility list and correct gas sterilization concentration requirements.

    Product
    Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2023-08-16

    Olympus Endoscope Reprocessor OER-Mini Labeling Revised for Device Compatibility

    Olympus revised labeling for the OER-Mini endoscope reprocessor. The company removed LF-V and LF-P endoscopes from the list of compatible devices and updated sterilization procedures.

    Product
    Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-08-16

    Olympus VISERA Tracheal Videoscope reprocessor compatibility and sterilization procedure revision

    Olympus is revising labeling for the VISERA Tracheal Intubation Videoscope to correct equipment compatibility information and update sterilization procedures. The device is no longer compatible with OER-Pro, OER-Elite, and OER-Mini reprocessors; sterilization and cleaning procedures have changed significantly.

    Product
    VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-08-16

    Olympus OER-Pro Endoscope Reprocessor Revised Labeling for Equipment Compatibility

    Olympus revised OER-Pro labeling because two endoscope models (LF-V, LF-P) are no longer compatible. Sterilization parameters and cleaning procedures have also changed.

    Product
    Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
    Category
    Distribution
    0 states