Auris Health, Inc
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Auris Health, Inc and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-02-25FDA-DeviceClass IIMONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
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.
- 2025-11-26FDA-DeviceClass IIMONARCH 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.
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