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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

MONARCH Bronchoscopy Platform Recalled for Robotic Arm Software Issue

Agency Publication Date: February 17, 2026
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Summary

Auris Health, Inc. has recalled 173 MONARCH Bronchoscopy Platforms because a software issue can cause the robotic arm to move into an unexpected position. If the application restarts at a specific point during setup, the system may reset to the patient's left side even if the right side was originally selected. This unexpected movement could cause the robotic arm to strike the patient or interfere with the endotracheal tube.

Risk

The software error may cause the robotic arm to move toward the patient's left side without warning, potentially resulting in physical contact with the patient or dislodging breathing tubes during a procedure.

What You Should Do

  1. Identify if your MONARCH Platform is affected by checking the Catalog Numbers (MON-000005-01, MON-000005-01R, MON-000006, MON-000006-RFB, or MON-000008) and Software Versions (2.2.2, 2.2.3, 2.2.4, 2.2.5, and 4.1.1).
  2. Check the serial number on your device. Affected serial numbers include 110024, 120088, 120057, 120046, 120058, 120015, 120160, and many others. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: MONARCH Platform, Bronchoscopy
Variants: Software version 2.2.2, Software version 2.2.3, Software version 2.2.4, Software version 2.2.5, Software version 4.1.1
Model / REF:
MON-000005-01
MON-000005-01R
MON-000006
MON-000006-RFB
MON-000008
Serial Numbers (173):
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
UDI:
10810068810803
10810068810988

Recall #: Z-1383-2026. Distributed worldwide.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98270
Status: Active
Manufacturer: Auris Health, Inc
Sold By: Hospital supply distributors; Direct medical sales
Manufactured In: United States
Units Affected: 173
Distributed To: 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

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.