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

Auris Health (J&J MedTech)

Robot types: Surgical robot, Endoluminal. Risk band: High RobotRisk index 45.4/100 (severity- and time-weighted incidents) · ranked 2 of 25 among Medical robotics companies with incidents (274 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. The pattern is one of sustained, high-severity regulatory scrutiny concentrated on a single device platform over a multi-year span.

Risk index

45.4/100RobotRisk index

21.8/100Median index across the 25 Medical robotics companies with incident history (274 tracked, 249 with none)

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

HighRisk band

Products and robot types

Industries: Medical robotics · Sectors: Hospitals and Health Care

Risk is scored per product and robot type: each incident is attributed to the product it names, or to the company's matching robot type.

Robot type	Share of company risk	Rank within type
Endoluminal	100%	1 of 2

Product	Robot type	Status	Incidents	Index
Monarch Platform	Endoluminal	shipping	3	45.4

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

S3 21 Jan 2026 · recall · FDA Class II recall: MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-0

Location not specified1 supporting source rowhigh confidence

Sev	Date	Supporting source row	Source
S3	21 Jan 2026	FDA Class II recall: MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-0	openFDA enforcement

S3 02 Aug 2024 · recall · FDA Class II recall: Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R.

Location not specified1 supporting source rowhigh confidence

Sev	Date	Supporting source row	Source
S3	02 Aug 2024	FDA Class II recall: Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R.	openFDA enforcement

S3 18 Oct 2023 · recall · FDA Class II recall: Monarch Platform

Location not specified1 supporting source rowhigh confidence

Sev	Date	Supporting source row	Source
S3	18 Oct 2023	FDA Class II recall: Monarch Platform	openFDA enforcement

Similar companies

Same industry, nearest RobotRisk band or score.

Cross-links and alerts

CSA company page

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