MONARCH Bronchoscope. Model Number: MBR-000211-B
FDA Recall Z-0543-2026 · Posted 2025-11-19
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Recalling FirmAuris Health, Inc
Recall StatusOpen, Classified
Product CodeQNW
Date Initiated2025-10-18
Product Quantity1,477 units
Reason for Recall
Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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