FDA Medical devices recall ·
MONARCH Bronchoscope recall
- Recall number
- Z-0543-2026
- Date
- (initiated October 18, 2025)
- Company / brand
- Auris Health, Inc
5490 Great America Pkwy, Santa Clara, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,477 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
MONARCH Bronchoscope. Model Number: MBR-000211-B
Why was it recalled?
Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: MBR-000211-B. Serial Number (Expiration Date): 1311677 (11/14/2024), 1311678 (11/14/2024), 1311679 (11/14/2024), 1311680 (11/14/2024), 1311681 (11/14/2024), 1311682 (11/14/2024), 1311683 (11/14/2024), 1311684 (11/14/2024), 1311685 (11/14/2024), 1311686 (11/14/2024), 1311687 (11/14/2024), 1311688 (11/14/2024), 1311722 (11/15/2024), 1311723 (11/15/2024), 1311724 (11/15/2024), 1311725 (11/15/2024), 1311726 (11/15/2024), 1311727 (11/15/2024), 1311730 (11/15/2024), 1311731 (11/15/2024), 2404220489 (11/21/2024), 2404220490 (11/21/2024), 2404220491 (11/21/2024), 2404220492 (11/21/2024), 2404220493 (11/21/2024), 2404220494 (11/21/2024), 2404220495 (11/21/2024), 2404220633 (11/21/2024), 2404220634 (11/21/2024), 2404220635 (11/21/2024), 2404220636 (11/21/2024), 2404230395 (11/22/2024), 2404230396 (11/22/2024), 2404230412 (11/22/2024), 2404230413 (11/22/2024), 2404230414 (11/22/2024), 2404230415 (11/22/2024), 2404230416 (11/22/2024), 2404230417 (11/22/2024), 2404230418 (11/22/2024), 2404230419 (11/22/2024), 2404250570 (11/28/2024), 2404250571 (11/28/2024), 2404290882 (11/28/2024), 2404290883 (11/28/2024), 2404290884 (11/28/2024), 2404290885 (11/28/2024), 2404290886 (11/29/2024), 2404290887 (11/29/2024), 2404290888 (11/29/2024), 2404290889 (11/29/2024), 2404290890 (11/29/2024), 2404290891 (11/29/2024), 2404290892 (11/29/2024), 2404290893 (11/29/2024), 2404290894 (11/29/2024), 2404290895 (11/29/2024), 2404290896 (11/29/2024), 2404300697 (11/29/2024), 2404300698 (11/29/2024),
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.
States: Alabama Arizona California Colorado Connecticut District of Columbia Florida Georgia Idaho Illinois Indiana Kentucky Massachusetts Michigan Mississippi Montana North Carolina Nebraska New Jersey New Mexico New York Ohio Oregon Pennsylvania South Carolina South Dakota Tennessee Virginia Vermont Washington West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0543-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.