Official recall record

Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and the

US FDA — Medical Devices · 2023-05-26 · United StatesClass II

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2023-05-26
Country of alert: United States
Alert level: Class II
Alert type: recall
Barcode (EAN/GTIN): 04953170331619
Brand on record: Olympus Corporation of the Americas

What the authority reported

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

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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Other recalls from this brand

All 21 official recall notices naming Olympus Corporation of the Americas on this site →

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