Auris Health, Inc: Medical Device Recall in 2026 - (Recall #: Z-1383-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software

Product Classification:

Class II

Date Initiated: January 21, 2026

Date Posted: February 25, 2026

Recall Number: Z-1383-2026

Event ID: 98270

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.

Status: Ongoing

Product Quantity: 173

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated