RegWardenFDA facility compliance records
Recall

Class II — Auris Health, Inc

Recalling firmAuris Health, Inc.
Registered facilityView this company's 2 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonDevice 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.
ProductMONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
Quantity173
DistributionWorldwide - 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.
Initiated2026-01-21
Classified2026-02-17
Recall numberZ-1383-2026
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Auris Health, Inc (Z-1383-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98270/

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