FDAMay 26, 2023device

VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

04953170340246

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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