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Auris Health, Inc FDA Recalls

7 recalls on file across devices, 0 of them Class I and 7 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-00000Class IIJan 21, 2026Device for bronchoscopic visualization, patient airway acces	Device for bronchoscopic visualization, patient airway access has software issue: if application restarts afte	Class IIDevices	Jan 21, 2026
MONARCH Bronchoscope. Model Number: MBR-000211-BClass IIOct 18, 2025Potential that product was leak tested with equipment outsid	Potential that product was leak tested with equipment outside of its expected operating range, resulting in br	Class IIDevices	Oct 18, 2025
Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MClass IIAug 2, 2024Endoscopy/bronchoscopy/urology devices may have a strain rel	Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords th	Class IIDevices	Aug 2, 2024
Monarch Platform (Urology), REF: MON-000007, MON-000007-RFBClass IIAug 2, 2024Endoscopy/bronchoscopy/urology devices may have a strain rel	Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords th	Class IIDevices	Aug 2, 2024
Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440wClass IIOct 18, 2023Their is the potential that software issues may result in f	Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.	Class IIDevices	Oct 18, 2023
Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440wClass IIOct 18, 2023Their is the potential that software issues may result in f	Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.	Class IIDevices	Oct 18, 2023
Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440wClass IIOct 18, 2023Their is the potential that software issues may result in f	Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.	Class IIDevices	Oct 18, 2023

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