Auris Health recalls
4 official recalls and safety alerts involving Auris Health since 2023-12, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Auris Health or the relevant agency.
- 2026-02-25
USAuris Health, Inc recalls MONARCH 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…
FDA · DeviceAuris Health, IncWorldwide - US Nationwide distribution in the states of MN, FL, NJ, NY, VA,…Official notice →- 2025-11-26
- US
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.
FDA · DeviceAuris Health, IncNationwide distribution to AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, MA,…Official notice → - 2024-10-16
- US
AURIS HEALTH INC recalls Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
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…
FDA · DeviceAURIS HEALTH INCWorldwide - US Nationwide distribution including in the states of MN, FL, NC,…Official notice → - 2023-12-13
- US
AURIS HEALTH INC recalls Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
FDA · DeviceAURIS HEALTH INCUS Distribution: AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, MA, MI,…Official notice →