Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1383-2026 — MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software

U.S. FDA — Device Enforcement · United States · 2026-01-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1383-2026
Date of alert
2026-01-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Auris Health, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10810068810803
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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