FDA recall Z-0543-2026

Auris Health, Inc · Class II · device

Product

MONARCH Bronchoscope. Model Number: MBR-000211-B

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.

Key facts

Status
Ongoing
Initiation date
2025-10-18
Report date
2025-11-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Santa Clara, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0543-2026