MONARCH Bronchoscope. Model Number: MBR-000211-B

FDA device recall Z-0543-2026 · posted 2025-11-19 · Open, Classified

Recall details

Recalling firm

Auris Health, Inc

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.

Action taken

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 MonarchSupport@its.jnj.com. 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 MonarchSupport@its.jnj.com 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 MonarchSupport@its.jnj.com. For Medical Information requests, please visit our website at https://www.jnjmedtech.com/mir.

Root cause

Process control

Status

Open, Classified

Product code

QNW

Quantity affected

1,477 units

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.

Date initiated

2025-10-18

Date posted

2025-11-19

Location

Santa Clara, CA

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