RobotRisk › Medical robotics › Auris Health (J&J MedTech)

Auris Health (J&J MedTech)

Products: surgical-robot, endoluminal-robot. Risk band: High RobotRisk index 45.7/100 (severity- and time-weighted incidents) · ranked 2 of 25 among Medical robotics companies with incidents (173 tracked).

Analyst brief

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. Auris Health (J&J MedTech)'s index of 45.7 ranks 2 of 25 companies in Medical robotics with incident history. The pattern is one of sustained, high-severity regulatory scrutiny concentrated on a single device platform over a multi-year span.

Risk index

45.7/100RobotRisk index

22.1/100Median index across the 25 Medical robotics companies with incident history (173 tracked, 148 with none)

2 of 25Rank in Medical robotics (of 25 with incident history)

HighRisk band

Incident timeline

Comparisons over time

Per-type breakdown

Incident type	Unique incidents	Share
recall	3	100%

Unique incident list

3 unique incidents on file for this company.

Sev	Date	Type	Location	Incident	Source
S3	21 Jan 2026	recall	—	FDA Class II recall: MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-0 · MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-	openFDA enforcement
S3	02 Aug 2024	recall	—	FDA Class II recall: Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. · Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005	openFDA enforcement
S3	18 Oct 2023	recall	—	FDA Class II recall: Monarch Platform · Monarch Platform	openFDA enforcement