BEUDAMED
    FDA Recall Open, Classified

    MONARCH Bronchoscope. Model Number: MBR-000211-B

    Recall: Z-0543-2026 · Initiated October 18, 2025

    Recall

    Recall Number
    Z-0543-2026
    Event Number
    97781
    Firm
    Auris Health, Inc
    FEI Number
    3017425975
    Product Code
    QNW
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    October 18, 2025
    Posted
    November 19, 2025
    Address
    5490 Great America Pkwy, Santa Clara, CA, 95054-3644

    Description

    MONARCH Bronchoscope. Model Number: MBR-000211-B

    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.

    Action

    Auris Health notified consignees via emailed "URGENT FIELD SAFETY NOTICE - DEVICE RECALL" letter dated 10/17/2025 on about 10/18/2025. Consignees were instructed to cease use of affected units immediately, forward the notification to any applicable personnel as well as customers if further distributed/transferred, and arrange for the return of all affected units. Consignees were also instructed to complete and return the Acknowledgement Form via email to [email protected]. Please return this form even if you no longer have or use the device subject to this notification. Please return any of the listed bronchoscopes in your possession to Auris Health, Inc. Please contact the MONARCH Support team at +1 (800) 434-0032 or via email at [email protected] for support in returning any impacted devices. If you have any questions regarding this letter or need support, please contact the MONARCH Support team at +1 (800) 434-0032 or via email at [email protected]. For Medical Information requests, please visit our website at https://www.jnjmedtech.com/mir.

    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.

    Quantity

    1,477 units