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

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

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

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

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.

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