Recall database

Auris Health, Inc recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–2 of 2 recalls

Class IIOngoingZ-1383-2026

Auris Health, Inc recalls MONARCH Platform

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 positi…

Bronchoscope (Flexible Or Rigid)
Software design

Auris Health, IncCAFeb 25, 2026

Class IIOngoingZ-0543-2026

Auris Health, Inc recalls MONARCH Bronchoscope. Model Number: MBR-000211-B

Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.

Reprocessed Bronchoscope
Process control

Auris Health, IncCANov 26, 2025