Olympus recalls OER-Elite endoscope reprocessors due to incompatibility with LF-V and LF-P endoscopes, requiring updated labeling for ETO gas sterilization.
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
Olympus is recalling OER-Elite endoscope reprocessors because they no longer support certain endoscope models (LF-V and LF-P). Using these with incompatible endoscopes risks improper sterilization and potential infection.
The OER-Elite reprocessor was updated to no longer support LF-V and LF-P endoscopes. This means these endoscopes cannot be safely reprocessed using the OER-Elite, potentially leading to improper sterilization and infection risks.
Endoscopists and medical facilities using Olympus OER-Elite reprocessors with LF-V or LF-P endoscopes are most at risk. The recall affects specific endoscope models and reprocessors.
Check for the OER-Elite reprocessor model. The recall includes units with serial numbers starting with 2201375 and last 4 digits less than 1375. LF-V and LF-P endoscopes are incompatible with this model.
Verify if your endoscope is LF-V or LF-P type, as these are incompatible with the OER-Elite reprocessor.
Ensure the reprocessor has updated labeling showing ETO gas sterilization at 100% concentration, not 12%.
The OER-Elite reprocessor no longer supports LF-V and LF-P endoscopes, requiring updated labeling for ETO gas sterilization at 100% concentration.
LF-V and LF-P endoscopes are incompatible with the OER-Elite reprocessor.
Check the serial number: units starting with 2201375 and last 4 digits less than 1375 are affected.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2344-2023 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2344-2023 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
