Class II

Medical Device Recall: MONARCH Bronchoscope. Model Number: MBR-000211-B

Auris Health, Inc · October 18, 2025

Reason for Recall

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

Distribution

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.

States Affected

NATIONWIDE

Quantity Affected

1,477 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0543-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.