The Recall Desk
HighFDA (Devices)·Z-2342-2023·Announced 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall involving changes to endoscope reprocessor labeling that affect equipment compatibility and sterilization procedures. While no illnesses or injuries have been reported, improper use of incompatible endoscopes or failure to follow updated sterilization parameters could result in inadequate disinfection in healthcare settings.

Plain-English summary

The FDA has issued a recall for the Olympus OER-Pro, OER-Elite, and OER-Mini endoscope reprocessors due to labeling revisions. These revisions reflect changes to equipment compatibility, sterilization procedures, and cleaning methods.

Olympus Corporation revised the labeling because two endoscope models—the LF-V and LF-P—are no longer compatible with the OER reprocessor devices. The sterilization conditions for ETO gas have been changed from 12% ethylene oxide to 100% ethylene oxide. Additionally, the reusable cleaning brush has been removed from the approved cleaning tools; only single-use brushes remain compatible.

Healthcare facilities using these reprocessors should immediately review the updated labeling and verify they do not attempt to reprocess LF-V or LF-P endoscopes. All facilities must follow the revised sterilization parameters when using the devices and use only single-use brushes for manual cleaning. For questions about the updated labeling, contact Olympus Corporation of the Americas.

The recalled product

Product
Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Endoscope Reprocessor
Hazard
  • incompatible-equipment
  • sterilization
  • labeling-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI-DI: 04953170258589 All serial numbers

Distribution

Distributed nationwide across the United States.

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