Drug recall
MONARCH Bronchoscope. Model Number: MBR-000211-B
FDA recall event 97781 · Class II · Auris Health, Inc
Key facts
| Event ID | 97781 |
|---|---|
| Recall numbers | Z-0543-2026 |
| Recalling firm | Auris Health, Inc |
| Product type | Devices |
| Products | MONARCH Bronchoscope. Model Number: MBR-000211-B |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks. |
| Initiation date | Oct 18, 2025 |
| Report date | Nov 26, 2025 |
| City | Santa Clara |
| State | CA |
| Country | United States |
| FEI number | 3017425975 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: