MONARCH Bronchoscope — Class II medical device recall Z-0543-2026
Ongoing recall by Auris Health, Inc, reported 2025-11-26, distributed nationwide. Potential that product was leak tested with equipment outside of its expected operating range, resulting in br
| Recall number | Z-0543-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Auris Health, Inc, Santa Clara, CA, United States |
| Recall initiated | 2025-10-18 |
| Classified | 2025-11-19 |
| Reported by FDA | 2025-11-26 |
| Distributed | Nationwide (US) |
| Quantity | 1,477 units |
| Reason classes | packaging |
| Serial numbers | 1311677, 1311678, 1311679, 1311680, 1311681, 1311682, 1311683, 1311684, 1311685, 1311686, 1311687, 1311688, 1311722, 1311723, 1311724, 1311725, 1311726, 1311727, 1311730, 1311731, 2404220489, 2404220490, 2404220491, 2404220492, 2404220493 and 475 more |
| Model numbers | MBR-000211-B |
Product
MONARCH Bronchoscope. Model Number: MBR-000211-B
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0543-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.