FDAClass IIMay 18, 2022

BF-MP160F: EVIS EXERA Bronchofibervideoscope recall

BF-MP160F: EVIS EXERA Bronchofibervideoscope

Why was BF-MP160F: EVIS EXERA Bronchofibervideoscope recalled?

Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization

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?

All serial numbers. UDI: 04953170289064

Product
BF-MP160F: EVIS EXERA Bronchofibervideoscope
Recalling firm
Olympus Corporation of the Americas
Quantity
292 units
Distribution
US Nationwide distribution.
Recall date
May 18, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls