MONARCH Bronchoscope. Model Number: MBR-000211-B
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | October 18, 2025 |
| Reported | November 26, 2025 |
| Recalling firm | Auris Health, Inc |
| Country / region | United States CA |
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.
Affected products
- MONARCH Bronchoscope. Model Number: MBR-000211-B
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