FDA recall, , Moderate risk
Auris Health MONARCH Bronchoscopy Platform
Monarch Platform, Bronchoscopy has a software issue that may cause unanticipated robotic arm positioning.
Summary by Recall Canary from the FDA notice
What happened
Auris Health, Inc of Santa Clara, California recalled the MONARCH Platform, Bronchoscopy, a device for bronchoscopic visualization and patient airway access, because of a software issue.
If the application restarts after patient-side selection, prior to bronchoscope loading, it will re-initialize to the patient-left position, and if the right position was previously selected, this may lead to unanticipated robotic arm positioning toward the patient-left, possibly resulting in contact with the patient or endotracheal tube.
The company began the recall on January 21, 2026, and the FDA added it to the Enforcement Report on February 17, 2026, with distribution nationwide and in Hong Kong, China, and Canada.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
- UDI-DI
- 10810068810803
- 10810068810988
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Minnesota, Florida, New Jersey, New York, Virginia, Wisconsin, Arizona, Alabama, Mississippi, Louisiana, Michigan, Massachusetts, Montana, Pennsylvania, West Virginia, Georgia, Delaware, Texas, California, Ohio, Indiana, South Carolina, Connecticut, North Dakota, Missouri, District of Columbia, Illinois, Nebraska, Idaho, Washington, North Carolina, Tennessee, Oregon, Colorado, South Dakota, New Mexico, Vermont, Maryland and the countries of Hong Kong, China, Canada.
- Company
- Auris Health, IncSanta Clara, California
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98270
- Recall number
- Z-1383-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
