FDAClass IIJanuary 17, 2024

Olympus Endoeye Flex Deflectable Videoscope recall

OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with a video system center, light source, documentation…

Why was Olympus Endoeye Flex Deflectable Videoscope recalled?

Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: 04953170310386 All Serial Numbers

Product
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with a video system center, light source, documentation…
Recalling firm
Olympus Corporation of the Americas
Quantity
271 units US
Distribution
Nationwide
Recall date
January 17, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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