MONARCH Platform — Class II medical device recall Z-1383-2026
Ongoing recall by Auris Health, Inc, reported 2026-02-25, distributed nationwide. Device for bronchoscopic visualization, patient airway access has software issue: if application restarts afte
| Recall number | Z-1383-2026 |
|---|---|
| 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 | 2026-01-21 |
| Classified | 2026-02-17 |
| Reported by FDA | 2026-02-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CN, HK |
| Quantity | 173 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 10810068810803, 10810068810988 |
| Serial numbers | 110013, 110016, 110017, 110020, 110021, 110022, 110024, 110025, 110026, 110027, 110028, 110029, 110030, 110031, 110032, 110033, 110034, 110035, 110036, 110038, 110039, 110041, 110043, 110045, 110046 and 147 more |
| Model numbers | MON-000005-01, MON-000005-01R, MON-000006, MON-000006-RFB, MON-000008 |
Product
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
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 patient-left position; and if right position was previously selected, this may lead to unanticipated robotic arm positioning toward patient-left, may result in contact with patient/endotracheal tube.
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-1383-2026. 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.