Recall archive / FDA device enforcement
MONARCH Bronchoscope. Model Number: MBR-000211-B — FDA record Z-0543-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 18, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Recalling firm
- Auris Health, Inc
- Quantity
- 1,477 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0543-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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), 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The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Nov 26, 2025
- Recall initiation date
- Oct 18, 2025
- Center classification date
- Nov 19, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.