Olympus recalls OER-Pro endoscope reprocessors due to labeling errors that may cause incompatible use with LF-V and LF-P endoscopes, risking improper 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-Pro endoscope reprocessors because their labeling incorrectly lists LF-V and LF-P endoscopes as compatible. This could lead to improper sterilization if these endoscopes are used with the reprocessor, potentially causing safety issues.
The OER-Pro reprocessor labeling error means LF-V and LF-P endoscopes are no longer compatible with the reprocessor. This could lead to improper sterilization if these endoscopes are processed using the reprocessor, potentially causing safety risks.
Endoscopists and medical facilities using Olympus OER-Pro reprocessors with LF-V or LF-P endoscopes. Those most at risk are users who have not updated their reprocessing protocols based on the labeling changes.
Check for the OER-Pro reprocessor model with serial numbers listed in the recall. The affected endoscopes are LF-V and LF-P types.
Check if your endoscopes are LF-V or LF-P types, as these are no longer compatible with the OER-Pro reprocessor.
The OER-Pro reprocessor labeling error incorrectly listed LF-V and LF-P endoscopes as compatible, which could lead to improper sterilization.
No, but you should check if your endoscopes are LF-V or LF-P types and update your reprocessing protocols accordingly.
Ensure these endoscopes are not processed using the OER-Pro reprocessor and follow the updated labeling instructions for compatible endoscopes.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2342-2023 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2342-2023 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.
