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Incident · Recall

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.

Occurred 2025-10-18 · Auris Health · Investigated by FDA

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

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Sources (1)

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?start_search=1&firmlegalnam=Auris&postdatefrom=01/01/2017&postdateto=12/31/2026&PAGENUM=100

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.
Methodology: Verified · 1 source (1 primary) · last reviewed 2026-08-09

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-08-09

Sources by quality tier

1
primary-fda-database
FDA database

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for Auris Health (J&J) recalls Monarch bronchoscopes over out-of-range leak-test results.

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