_Incident · Recall_

# Auris Health (J&J) recalls Monarch bronchoscopes over out-of-range leak-test results

Canonical ID: `3c523f25-07af-4809-a31c-c03c6cb2e163`

- **Occurred:** 2025-10-18
- **Kind:** `recall`
- **Status (derived):** active
- **Company:** [Auris Health](/companies/auris-health.md) (id: `df69ac5c-53c1-4fa6-94d2-8f377e9bf87c`)

Auris Health recalled Monarch bronchoscopes over out-of-range leak-test results indicating possible loss of fluid-ingress protection. The largest Monarch recall to date at 1,477 units. Source: FDA Class 2 device recall Z-0543-2026, accessdata.fda.gov / openFDA enforcement.

## Sources (0)

_No sources on file._

## Common questions

### What happened in Auris Health (J&J) recalls Monarch bronchoscopes over out-of-range leak-test results?

Auris Health recalled Monarch bronchoscopes over out-of-range leak-test results indicating possible loss of fluid-ingress protection. The largest Monarch recall to date at 1,477 units. Source: FDA Class 2 device recall Z-0543-2026, accessdata.fda.gov / openFDA enforcement.

### When did this incident occur?

The incident is recorded as occurring on October 18, 2025 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.

### Who was involved in Auris Health (J&J) recalls Monarch bronchoscopes over out-of-range leak-test results?

The incident is recorded as involving Auris Health on the DEPLOY registry. No specific robot model is linked to this incident in the registry.

### Has anyone responded to Auris Health (J&J) recalls Monarch bronchoscopes over out-of-range leak-test results?

No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.

### What is the current status of Auris Health (J&J) recalls Monarch bronchoscopes over out-of-range leak-test results?

This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.


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