Quick Facts at a Glance
- Recall Date
- January 21, 2026
- Hazard Level
- HIGH
- Brand
- Auris Health
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Auris Health
- Product type
- Bronchoscopy Device
- Model numbers
- 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 +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 21, 2026
Reported by FDA DEVICE
February 25, 2026
RecallRadar source check
March 4, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Auris Health, Inc or your healthcare provider for instructions
About This Product
The MONARCH Platform bronchoscopy device assists healthcare professionals with bronchoscopic visualization and patient airway access. It is commonly used in medical procedures to help diagnose and treat airway issues.
Why This Is Dangerous
The device's software issue can cause the robotic arm to reposition unexpectedly, which may lead to contact with the patient or endotracheal tube during procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
This recall can significantly affect medical practices using the device, delaying procedures and requiring immediate alternatives for patient care.
Practical Guidance
How to identify if yours is affected
- Verify the catalog number on your device
- Check the software version against the recalled versions
- Look for serial numbers listed in the recall notice
Where to find product info
Catalog numbers and software versions can typically be found on the device's identification plate or user manual.
What timeline to expect
Expect refund processing to take 4-6 weeks once the manufacturer receives your request.
If the manufacturer is unresponsive
- Document all communication attempts with the manufacturer
- Reach out to consumer protection agencies
- Consult legal advice if necessary
How to prevent similar issues
- Look for devices with updated software and safety certifications
- Research the manufacturer's history for recalls
- Consult with peers about device reliability before purchase
Documentation advice
Keep all correspondence related to the recall, including emails, receipts, and photos of the device.
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Product Details
The recalled MONARCH Platform bronchoscopy devices include catalog numbers MON-000005-01, MON-000005-01R, MON-000006, MON-000006-RFB, and MON-000008. These devices were sold worldwide, including states like MN, FL, NJ, NY, and others.
Key Facts
- Software version 2.2.2 to 4.1.1 affected
- Potential for robotic arm mispositioning
- Nationwide distribution in the U.S. and Canada
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Safety Guide
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