Redwood City, CA, United States
AURIS HEALTH INC recalls
5 recalls recorded since 2018, most recently on 21 January 2026. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)4
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 21 January 2026
- 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 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.
- Distribution
- Worldwide - US Nationwide distribution in the states of MN, FL, NJ, NY, VA, WI, AZ, AL, MS, LA, MI, MA, MT, PA, WV, GA, DE, TX, CA, OH, IN, SC, CT, ND, MO, DC, IL, NE, ID, WA, NC, TN, OR, CO, SD, NM, VT, MD and the countries of Hong Kong, China, Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1383-2026
- MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
Ongoing Class II Medical devices
- Recall started
- 18 October 2025
- 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.
- Distribution
- Nationwide distribution to AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, MA, MI, MS, MT, NC, NE, NJ, NM, NY, OH, OR, PA, SC, SD, TN, VA, VT, WA, WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0543-2026
- MONARCH Bronchoscope. Model Number: MBR-000211-B
Ongoing Class II Medical devices
- Recall started
- 2 August 2024
- 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 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.
- Distribution
- Worldwide - US Nationwide distribution including in the states of MN, FL, NC, AK, NJ, NY, VA, WI, AZ, MS, LA, MI, MA, MT, WV, GA, DE, TX, CA, OH, IN, SC, PA, CT, ND, MO, DC, IL, NE, ID, WA, TN, OR, AL, SD, CO, KY, NM, VT, MD and the countries of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0051-2025, Z-0052-2025
- Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
- Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
Ongoing Class II Medical devices
- Recall started
- 18 October 2023
- Reason
- Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
- Distribution
- US Distribution: 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, WI & WV.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0450-2024, Z-0449-2024, Z-0448-2024
- Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
- Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w
- Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
Terminated Class II Medical devices
- Recall started
- 19 April 2019
- Terminated
- 19 January 2022
- Reason
- Reports of aspirating biopsy needle breakage
- Distribution
- US nationwide distribution to the states of: CT, FL, MI, OK, TN, MS, CA, MN, OH, PA, and IL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0025-2020
- Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.