Reported Nov 26, 2025 · Ongoing
MONARCH Bronchoscope. Model Number: MBR-000211-B
Auris Health, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Auris Health, Inc · 5490 Great America Pkwy · Santa Clara, CA · 95054-3644
Is this the product you have?
- MONARCH Bronchoscope
- Model NumberMBR-000211-B
- Lot codes and dates
- Model NumberMBR-000211-B
- Serial Number (Expiration Date)
1,304 of 1,304 codes
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)
- Amount recalled
- 1,477 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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