FDA-Device2025-11-26Class IIPROCESSING DEFECT
MONARCH Bronchoscope. Model Number: MBR-000211-B
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.
Intended for
Adults
Illnesses reported
None reported
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-0543-2026Want us to check the next one for you?
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