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Auris Health, Inc recalls MONARCH Bronchoscope. Model Number: MBR-000211-B
Recalled November 26, 2025 · FDA recall Z-0543-2026 · Auris Health
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. · FDA Class II
Units
1,477 units
Sold at
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.
Description
Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.
Product
MONARCH Bronchoscope. Model Number: MBR-000211-B
Manufacturer(s)
Auris Health, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →