Drug recall
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01, MON-000005-01R, MON-000006, MON-000006-RFB…
FDA recall event 98270 · Class II · Auris Health, Inc
Key facts
| Event ID | 98270 |
|---|---|
| Recall numbers | Z-1383-2026 |
| Recalling firm | Auris Health, Inc |
| Product type | Devices |
| Products | MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application will re-initialize to… |
| Initiation date | Jan 21, 2026 |
| Report date | Feb 25, 2026 |
| 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: