Recall Z-0543-2026 ยท QNW Reprocessed Bronchoscope
Auris Health, Inc
MONARCH Bronchoscope. Model Number: MBR-000211-B
| Date | Nov 19, 2025 (initiated Oct 18, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| 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 MonarchSupport@its.jnj.com. Please return this form even if you no longer have or use the device subject to this notification. Please retur |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K231473 | Monarch Bronchoscope Auris Health, Inc., A Johnson and Johnson Family Company, Nov 28, 2023 |