Auris Health, Inc recalls MONARCH Bronchoscope.

Recalling company

Auris Health, Inc

Product

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Oct 18, 2025

Reported

Nov 26, 2025

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.

Status

Ongoing

Quantity

1,477 units

Lot / codes

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),

Company location

Santa Clara, CA

Recall type

Voluntary: Firm initiated

Recall number

Z-0543-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0543-2026 in the FDA Enforcement Report. Also see FDA recall press releases.