Auris Health Recalls
8 recalls on record · November 27, 2019 to February 25, 2026 · Medical Devices
Recalls by year
19
23
24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 25, 2026Medical DevicesFDA
Auris Health, Inc recalls MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-00000
Hazard: 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.
November 26, 2025Medical DevicesFDA
Auris Health, Inc recalls MONARCH Bronchoscope. Model Number: MBR-000211-B
Hazard: Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.
October 16, 2024Medical DevicesFDA
AURIS HEALTH INC recalls Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
Hazard: Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion, and if the user (e.g., operating room staff) touches exposed wires or conductive fluids in contact with the exposed wires, there is a chance of electrical shock.
October 16, 2024Medical DevicesFDA
AURIS HEALTH INC recalls Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, M
Hazard: Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion, and if the user (e.g., operating room staff) touches exposed wires or conductive fluids in contact with the exposed wires, there is a chance of electrical shock.
December 13, 2023Medical DevicesFDA
AURIS HEALTH INC recalls Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
Hazard: Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
December 13, 2023Medical DevicesFDA
AURIS HEALTH INC recalls Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w
Hazard: Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
December 13, 2023Medical DevicesFDA
AURIS HEALTH INC recalls Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
Hazard: Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
November 27, 2019Medical DevicesFDA
AURIS HEALTH INC recalls Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
Hazard: Reports of aspirating biopsy needle breakage