Z-1383-2026 Class II Ongoing
FDA device recall Z-1383-2026 was initiated by Auris Health, Inc on January 21, 2026 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 173.
Recall Details
- Product Type
- Devices
- Report Date
- February 25, 2026
- Initiation Date
- January 21, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 173
Product Description
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
Reason for Recall
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.
Distribution Pattern
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.
Code Information
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