Auris Health recalls
Auris Health appears in 8 official U.S. recall notices indexed by RecallRadar, most recently on 2026-02-25.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 8 |
|---|---|
| Published | 2019-11-27 to 2026-02-25 |
| By agency | FDA Device (8) |
| By classification | Class II (8) |
| By status | ongoing (7), terminated (1) |
| Distribution named in notices | AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OR, PA, SC, SD, TN, TX, US, WI, WV |
Recalls
- MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
FDA Device · Class II · 2026-02-25 · Auris Health
Reason: 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 posit… - MONARCH Bronchoscope
FDA Device · Class II · 2025-11-26 · Auris Health
Reason: Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks. - Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
FDA Device · Class II · 2024-10-16 · Auris Health
Reason: 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… - Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB
FDA Device · Class II · 2024-10-16 · Auris Health
Reason: 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… - Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
FDA Device · Class II · 2023-12-13 · Auris Health
Reason: Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view. - Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
FDA Device · Class II · 2023-12-13 · Auris Health
Reason: Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view. - Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w
FDA Device · Class II · 2023-12-13 · Auris Health
Reason: Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view. - Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
FDA Device · Class II · 2019-11-27 · Auris Health
Reason: Reports of aspirating biopsy needle breakage