Olympus recalls VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V for incompatible reprocessing with OER-Pro, OER-Elite, OER-Mini endoscope reprocessors. This affects airway management devices used in medical settings.
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 its VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V for airway management. The recall is due to labeling issues that make these scopes incompatible with certain endoscope reprocessors, which could lead to improper sterilization and safety risks.
The OLYMPUS LF Type V and LF-P scopes are no longer compatible with OER-Pro, OER-Elite, and OER-Mini reprocessors. This change requires a shift from 12% EtO gas sterilization to 100% EtO gas sterilization, and removes reusable cleaning brushes. Using the device with incompatible reprocessors could lead to improper sterilization and potential safety issues.
Healthcare professionals using the VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V for airway management. Patients and staff at medical facilities using the device may be at risk if improper sterilization occurs.
The VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V is used for airway management. Check the serial number on the device, which is part of the UDI-DI: 04953170340246.
Verify if your VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V is compatible with your endoscope reprocessor by checking the manufacturer's labeling.
The recall is due to updated labeling that shows the OLYMPUS LF Type V and LF-P scopes are no longer compatible with OER-Pro, OER-Elite, and OER-Mini reprocessors. This requires a change in sterilization procedures.
Check if your device is compatible with your reprocessor by reviewing the updated labeling. If incompatible, follow the manufacturer's instructions for proper sterilization using 100% EtO gas.
The primary risk is improper sterilization if the device is used with incompatible reprocessors, which could lead to potential safety issues. However, the recall does not indicate immediate danger to users.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2340-2023 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2340-2023 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.