Class II — Potential Health Hazard

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

MONARCH Bronchoscope. Model Number: MBR-000211-B Recalled by Auris Health, Inc Due to Potential that product was leak tested with equipment...

Date: October 18, 2025
Company: Auris Health, Inc
Status: Ongoing
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 Auris Health, Inc directly.

Affected Products

MONARCH Bronchoscope. Model Number: MBR-000211-B

Quantity: 1,477 units

Why Was This Recalled?

Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Auris Health, Inc

Auris Health, Inc has 2 total recalls tracked by RecallDetector.

Related Recalls

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