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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

Intuitive Da Vinci 5 Surgical System Recalled for User Interface Error

Agency Publication Date: February 18, 2026
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Summary

Intuitive Surgical, Inc. is recalling 12 Da Vinci 5 surgical systems (model 380730) due to a software error in version P1.2.1. This error can cause the user interface content to disappear from external or tower monitors during minimally invasive surgery. These units were distributed in Louisiana, Massachusetts, New York, Pennsylvania, Texas, and Virginia.

Risk

The loss of user interface content on a monitor during a surgical procedure could lead to a delay in the operation or loss of critical visual information for the surgical team. No injuries have been reported in the recall data.

What You Should Do

  1. Identify if your surgical system is affected by checking for the Da Vinci 5 Console (ASSY, DV5 CONSOLE, IS5000), Model/Catalog Number 380730, with software version P1.2.1 and UDI-DI 00886874119747 (GTIN 0886874119747).
  2. Stop using the recalled device.
  3. Contact the manufacturer, Intuitive Surgical, Inc., or your distributor to arrange for a software correction, return, or replacement.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions.

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: Da Vinci 5 ASSY, DV5 CONSOLE, IS5000
Variants: Software version P1.2.1
Model / REF:
380730
UDI:
00886874119747
GTIN:
0886874119747

Recall Number: Z-1428-2026. Used for minimally invasive surgery.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98200
Status: Active
Manufacturer: Intuitive Surgical, Inc.
Sold By: Intuitive Surgical, Inc.
Manufactured In: United States
Units Affected: 12
Distributed To: Louisiana, Massachusetts, New York, Pennsylvania, Texas, Virginia

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.