United StatesMONARCH Bronchoscope, Model MBR-000211-B (1,477 units) from Auris Health, Inc. is affected; units were distributed nationwide 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 and WV. The bronchoscope was recalled because the product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.
What's being recalled
MONARCH Bronchoscope. Model Number: MBR-000211-B
Recalling firm: Auris Health, Inc, Santa Clara, CA, United States.
How to identify it
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), 2404300699 (11/29/2024), 2404300700 (11/29/2024), 2404300701 (11/29/2024), 2404300702 (11/29/2024), 2404300703 (11/29/2024), 2404300704 (11/29/2024), 2404300705 (11/29/2024), 2404300706 (11/29/2024), 2404300707 (11/29/2024), 2404300708 (11/29/2024), 2404300709 (11/29/2024), 2405010808 (12/01/2024), 2405010809 (12/01/2024), 2405020637 (12/01/2024), 2405020638 (12/01/2024), 2405020639 (12/01/2024), 2405020640 (12/01/2024), 2405020641 (12/01/2024), 2405020642 (12/01/2024), 2405080524…
The hazard
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 to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)