Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus Recalled by Olympus Corporation of the Americas Due to The BF-Q180 bronchoscope is being recalled because it...

Date: August 31, 2020
Company: Olympus Corporation of the Americas
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Olympus Corporation of the Americas directly.

Affected Products

Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial numbers - Product Usage: designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.

Quantity: 5,813 devices distributed worldwide, including 2,648 devices distributed throughout U.S.A.

Why Was This Recalled?

The BF-Q180 bronchoscope is being recalled because it does not have a 510(k) clearance, and the device is associated with a higher rate of patient infections than other comparable OMSC bronchoscopes.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Olympus Corporation of the Americas

Olympus Corporation of the Americas has 378 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report