FDAClass IOctober 22, 2025

Bronchovideoscope Olympus Bf-h1100 recall

BRONCHOVIDEOSCOPE OLYMPUS BF-H1100

Why was Bronchovideoscope Olympus Bf-h1100 recalled?

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

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?

Model No. BF-H1100; UDI: 4953170424229; All Serial No.

Product
BRONCHOVIDEOSCOPE OLYMPUS BF-H1100
Recalling firm
Olympus Corporation of the Americas
Quantity
0 units US; 1,867 units OUS
Distribution
US Nationwide Distribution.
Recall date
October 22, 2025
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls