FDA-Device2025-11-26Class II
MONARCH Bronchoscope. Model Number: MBR-000211-B
Auris Health, Inc
Hazard
Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.
Sold states
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.
Affected count
1,477 units
Manufactured in
5490 Great America Pkwy, Santa Clara, CA, United States
Products
MONARCH Bronchoscope. Model Number: MBR-000211-B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0543-2026Don't want to check this manually?
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