Recall archive / FDA device enforcement
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-00... — FDA record Z-1383-2026
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 Jan 21, 2026. 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 Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
- Reason
- Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application will re-initialize to patient-left position; and if right position was previously selected, this may lead to unanticipated robotic arm positioning toward patient-left, may result in contact with patient/endotracheal tube.
- Classification
- Class II
- Recalling firm
- Auris Health, Inc
- Quantity
- 173
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1383-2026
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 | Software versions: 2.2.2, 2.2.3, 2.2.4, 2.2.5, and 4.1.1. UDI-DI: 10810068810803, 10810068810988. Serial Numbers: 110024, 120088, 120057, 120046, 120058, 120015, 120160, 120068, 120081, 120056, 110028, 120128, 120017, 120089, 120075, 110016, 120031, 120169, 120113, 120168, 120055, 120014, 120060, 120174, 120195, 120026, 110038, 120124, 120194, 110027, 110035, 120123, 120091, 120007, 110022, 120006, 120152, 120004, 120120, 120041, 120106, 110034, 120126, 120082, 120151, 120051, 120020, 120153, 120193, 120170, 120108, 120037, 120074, 120199, 120130, 120095, 110026, 120096, 120009, 120111, 120022, 120054, 120163, 110045, 120027, 110039, 120090, 120141, 120072, 120155, 110049, 120143, 110047, 120125, 120052, 110052, 120100, 120050, 120098, 120045, 120131, 110020, 110030, 110032, 110021, 120013, 120105, 120136, 120192, 110017, 120029, 120139, 110031, 120137, 120053, 110029, 120028, 120034, 120085, 120019, 120049, 120209, 120144, 120161, 120001, 110033, 120145, 120127, 110046, 110043, 120011, 120070, 120076, 120134, 120117, 110025, 120077, 120149, 120191, 120102, 120002, 120156, 120010, 120171, 120003, 120023, 120146, 120188, 120043, 120071, 120042, 120196, 110051, 120065, 120172, 120116, 120150, 120066, 120166, 120033, 110013, 120079, 120008, 120086, 120032, 120073, 1806P1, 120197, 120080, 120078, 14, 120012, 110041, 120084, 120219, 110036, 120181, 120083, 120067, 120021, 120216, 120217, 120218, 120069, 120204, 120207, 120215, 120237, 120208, 120213, 120164, 120132, 120182 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - US Nationwide distribution in the states of MN, FL, NJ, NY, VA, WI, AZ, AL, MS, LA, MI, MA, MT, PA, WV, GA, DE, TX, CA, OH, IN, SC, CT, ND, MO, DC, IL, NE, ID, WA, NC, TN, OR, CO, SD, NM, VT, MD and the countries of Hong Kong, China, Canada.
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
- Feb 25, 2026
- Recall initiation date
- Jan 21, 2026
- Center classification date
- Feb 17, 2026
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.