Products: surgical-robot, endoluminal-robot. Risk band: Elevated RobotRisk index 27.4/100 (incidents/exposure, time-weighted) · 97th percentile of 162 medical robotics companies.
The record contains three entries, all FDA Class II recalls of the Monarch Platform bronchoscopy/endoscopy system, dated 2023, 2024, and January 2026, each rated severity 3. The recurrence of recalls against the same platform and catalog numbers across three separate years indicates a repeated rather than one-time regulatory action. The index of 27.6 and 96.9 percentile place Auris Health at the top of the medical-robotics category, driven entirely by regulator-issued findings rather than press reporting. The pattern is one of sustained, high-severity regulatory scrutiny concentrated on a single device platform over a multi-year span.
| Sev | Date | Type | Location | Incident | Source |
|---|---|---|---|---|---|
| S3 | 01/21 2026 |
recall | — | FDA Class II recall: MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-0 · MONARCH Platform, Bronchoscopy, Catalo… | openFDA enforcement |
| S3 | 08/02 2024 |
recall | — | FDA Class II recall: Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. · Monarch Platform (Endoscopy), REF: MON… | openFDA enforcement |
| S3 | 10/18 2023 |
recall | — | FDA Class II recall: Monarch Platform · Monarch Platform | openFDA enforcement |