Auris Health (J&J) recalls Monarch over unanticipated robotic arm positioning toward patient-left
[RECALL]Jan 21, 2026 · Auris Health · Monarch Platform · Surgical robots
Failure Mode
RECALL
Event Date
Jan 21, 2026
Primary Entity
Auris Health
Robotic Platform
Monarch Platform
Jurisdiction / Location
Surgical robots
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
Auris Health recalled the Monarch bronchoscopy platform because a software issue could cause unanticipated robotic-arm positioning toward patient-left, risking contact with the patient or endotracheal tube. 173 units. Source: FDA Class 2 device recall Z-1383-2026, openFDA enforcement / accessdata.fda.gov.
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 over unanticipated robotic arm positioning toward patient-left?
Auris Health recalled the Monarch bronchoscopy platform because a software issue could cause unanticipated robotic-arm positioning toward patient-left, risking contact with the patient or endotracheal tube. 173 units. Source: FDA Class 2 device recall Z-1383-2026, openFDA enforcement / accessdata.fda.gov.
When did this incident occur?
The incident is recorded as occurring on January 21, 2026 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 over unanticipated robotic arm positioning toward patient-left?
Monarch Platform by Auris Health is the recorded robot involved in this incident.
Has anyone responded to Auris Health (J&J) recalls Monarch over unanticipated robotic arm positioning toward patient-left?
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 over unanticipated robotic arm positioning toward patient-left?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.