Class II U.S. Food and Drug Administration

Auris Health, Inc Monarch Bronchoscope recall: Potential that product was leak tested with equipment outside of its expected

Recall published 11 months ago

Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0543-2026
Published
November 26, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Auris Health, Inc
Product type
Medical devices
Units affected
1,477 units
Distribution
Nationwide
Made in
United States
Lot / code info
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 (12/07/2024), 2405080525 (12/07/2024), 2405080526 (12/07/2024), 2405080527 (12/07/2024), 2405080528 (12/07/2024), 2405080529 (12/07/2024), 2405080636 (12/07/2024), 2405090564 (12/08/2024), 2405090565 (12/08/2024), 2405090566 (12/08/2024), 2405090567 (12/08/2024), 2405090568 (12/08/2024), 2405090569 (12/08/2024), 2405090570 (12/08/2024), 2405090571 (12/08/2024), 2405090572 (12/08/2024), 2405090573 (12/08/2024), 2405160716 (12/19/2024), 2405160717 (12/19/2024), 2405160718 (12/19/2024), 2405200526 (12/19/2024), 2405200527 (12/19/2024), 2405200528 (12/19/2024), 2405200529 (12/19/2024), 2405200530 (12/19/2024), 2405200531 (12/19/2024), 2405200532 (12/19/2024), 2405200725 (12/19/2024), 2405200726 (12/19/2024), 2405200727 (12/19/2024), 2405200797 (12/19/2024), 2405200798 (12/19/2024), 2405200799 (12/19/2024), 2405200800 (12/19/2024), 2405200802 (12/19/2024), 2405200803 (12/19/2024), 2405200804 (12/19/2024), 2405200805 (12/19/2024), 2405200806 (12/19/2024), 2405200807 (12/19/2024), 2405200808 (12/19/2024), 2405200809 (12/19/2024), 2405200810 (12/19/2024), 2405200811 (12/19/2024), 2405200812 (12/19/2024), 2405200813 (12/19/2024), 2405200814 (12/19/2024), 2405200815 (12/20/2024), 2405200816 (12/20/2024), 2405210440 (12/20/2024), 2405210441 (12/20/2024), 2405210442 (12/20/2024), 2405210803 (12/20/2024), 2405210804 (12/20/2024), 2405210805 (12/20/2024), 2405210923 (12/20/2024), 2405210924 (12/20/2024), 2405210925 (12/20/2024), 2405210926 (12/20/2024), 2405210927 (12/20/2024), 2405210928 (12/20/2024), 2405210929 (12/20/2024), 2405210930 (12/20/2024), 2405210931 (12/20/2024), 2405210932 (12/20/2024), 2405210933 (12/20/2024), 2405210934 (12/20/2024), 2405210935 (12/20/2024), 2405210937 (12/20/2024), 2405210938 (12/20/2024), 2405210939 (12/20/2024), 2405210940 (12/20/2024), 2405210941 (12/20/2024), 2405210942 (12/20/2024), 2405210943 (12/20/2024), 2405220111 (12/21/2024), 2405220112 (12/21/2024), 2405220113 (12/21/2024), 2405220114 (12/21/2024), 2405220115 (12/21/2024), 2405220174 (12/21/2024)…

Products covered by this recall

MONARCH Bronchoscope. Model Number: MBR-000211-B

What to do about Device

Auris Health, Inc — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Auris Health, Inc — 5490 Great America Pkwy, Santa Clara, CA, 95054-3644

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Auris Health, Inc medical devices 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. Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Device enforcement record, and contact the company if you are unsure.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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