Auris Health (J&J) recalls Monarch bronchoscopes over out-of-range leak-test results
[RECALL]Oct 18, 2025 · Auris Health · Monarch Platform · Surgical robots
Failure Mode
RECALL
Event Date
Oct 18, 2025
Primary Entity
Auris Health
Robotic Platform
Monarch Platform
Jurisdiction / Location
Surgical robots
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
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.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
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
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
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Details
Incident Context & FAQ
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.
What robot was involved in Auris Health (J&J) recalls Monarch bronchoscopes over out-of-range leak-test results?
Monarch Platform by Auris Health is the recorded robot involved in this incident.
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.