Recall Z-0543-2026— Auris Health, Inc

Name: FDA recall Z-0543-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-18

Class II · Ongoing

Class II FDA medical device recall by Auris Health, Inc, initiated 2025-10-18. It names one FDA 510(k) clearance: K231473. 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..

Recalling firm: Auris Health, Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-10-18
Firm location: Santa Clara, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K231473 — Monarch BronchoscopeAuris Health, Inc., A Johnson and Johnson Family Company·cleared 2023-11-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MONARCH Bronchoscope. Model Number: MBR-000211-B

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.