Auris Health, Inc recalls MONARCH Bronchoscope. Model Number: MBR-000211-B

Recall date

October 18, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0543-2026

FDA classification

Class II

Brand / firm

Auris Health, Inc

Sold / distributed

Nationwide distribution to AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, MA, MI, MS, MT, NC, NE, NJ, NM, NY, OH, OR, PA, SC, SD, TN, VA, VT, WA, WV.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MONARCH Bronchoscope. Model Number: MBR-000211-B