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MONARCH™ Bronchoscope
Auris Health, Inc. · Model MBR-000211-B · UDI-DI 10810068811138
QNW
Prescription
1
510(k) clearances
20
Adverse events
1
Recalls
8
Facilities
Description
Reprocessed Bronchoscope
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-18 | Auris Health, Inc | Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.