Olympus Corporation of the Americas: Medical Device Recall in 2023 - (Recall #: Z-2344-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.

Product Classification:

Class II

Date Initiated: May 26, 2023

Date Posted: August 16, 2023

Recall Number: Z-2344-2023

Event ID: 92633

Reason for Recall:

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

Status: Ongoing

Product Quantity: 1063 units

Code Information:

UDI-DI: 04953170404047 Serial Numbers: 2201375 and the last 4 digits less than 1375

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated