FDA Device recall Z-0543-2026
MONARCH Bronchoscope
- FDA Device
- Class II
- ongoing
- Published 2025-11-26
On 2025-11-26 the FDA classified a Class II recall of MONARCH Bronchoscope by Auris Health, citing potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0543-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-18 |
| Published | 2025-11-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Auris Health |
| Distribution | US |
Product
MONARCH Bronchoscope. Model Number: MBR-000211-B
Reason
Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.
Identifiers
| code_info | Model Number: MBR-000211-B. Serial Number (Expiration Date): 1311677 (11/14/2024), 1311678 (11/14/2024), 1311679 (11/14…Model Number: MBR-000211-B. Serial Number (Expiration Date): 1311677 (11/14/2024), 1311678 (11/14/2024), 1311679 (11/14/2024), 1311680 (11/14/2024), 1311681 (11/14/2024), 1311682 (11/14/2024), 1311683 (11/14/2024), 1311684 (11/14/2024), 1311685 (11/14/2024), 1311686 (11/14/2024), 1311687 (11/14/2024), 1311688 (11/14/2024), 1311722 (11/15/2024), 1311723 (11/15/2024), 1311724 (11/15/2024), 1311725 (11/15/2024), 1311726 (11/15/2024), 1311727 (11/15/2024), 1311730 (11/15/2024), 1311731 (11/15/2024), 2404220489 (11/21/2024), 2404220490 (11/21/2024), 2404220491 (11/21/2024), 2404220492 (11/21/2024), 2404220493 (11/21/2024), 2404220494 (11/21/2024), 2404220495 (11/21/2024), 2404220633 (11/21/2024), 2404220634 (11/21/2024), 2404220635 (11/21/2024), 2404220636 (11/21/2024), 2404230395 (11/22/2024), 2404230396 (11/22/2024), 2404230412 (11/22/2024), 2404230413 (11/22/2024), 2404230414 (11/22/2024), 2404230415 (11/22/2024), 2404230416 (11/22/2024), 2404230417 (11/22/2024), 2404230418 (11/22/2024), |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0543-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.