medical Class II Updated 2023-08-16

Olympus Corporation of the Americas recalls Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with

Recalled Product

Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display monitor and other ancillary equipment for management of Endotracheal Tube


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 04953170051098 All serial numbers
View official government recall

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