The Recall Desk
Severity pendingFDA (Devices)·Z-1383-2026·Announced 2026-02-25

MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-0

Pending LLM rewrite. Source: FDA_DEVICE Z-1383-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application will re-initialize to patient-left position; and if right position was previously selected, this may lead to unanticipated robotic arm positioning toward patient-left, may result in contact with patient/endotracheal tube.

The recalled product

Product
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
Manufacturer
Auris Health, Inc
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Software versions: 2.2.2
  • 2.2.3
  • 2.2.4
  • 2.2.5
  • and 4.1.1. UDI-DI: 10810068810803
  • 10810068810988. Serial Numbers: 110024
  • 120088
  • 120057
  • 120046
  • 120058
  • 120015
  • 120160
  • 120068
  • 120081
  • 120056
  • 110028
  • 120128
  • 120017
  • 120089
  • 120075

Distribution

Distributed nationwide across the United States.

Related recalls

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