Quick Facts at a Glance
- Recall Date
- November 17, 2025
- Hazard Level
- HIGH
- Brand
- Intuitive Surgical
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 6 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
- Intuitive Surgical
- Product type
- Surgical System
- Model numbers
- UDI-DI: 00886874119747 GTIN: 0886874119747 with software version P1.2.1
- Sold at
- Unknown
- Where affected
- LA, MA, NY, PA, TX, VA
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 17, 2025
Reported by FDA DEVICE
February 25, 2026
RecallRadar source check
March 4, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Intuitive Surgical, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
The Da Vinci 5 Console is part of a robotic surgical system designed for minimally invasive procedures. Its advanced technology allows surgeons to perform complex surgeries with precision and control.
Why This Is Dangerous
The software error can disrupt the visual interface used by surgeons, making it difficult to monitor and control surgical procedures effectively. This can lead to operational failures during critical moments.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall poses significant safety concerns for ongoing surgeries and could lead to operational downtime for healthcare facilities.
Practical Guidance
How to identify if yours is affected
- Check the model number on your Da Vinci 5 Console to see if it matches the recalled model 380730.
- Verify the software version; the issue arises from version P1.2.1.
- Consult with your healthcare provider for confirmation.
Where to find product info
The model number can typically be found on the back or bottom of the console, along with the software version in the device settings.
What timeline to expect
Expect a timeline of 4-6 weeks for processing refunds or replacements once the manufacturer has been contacted.
If the manufacturer is unresponsive
- Document all communication attempts with the manufacturer.
- Reach out to your healthcare provider for assistance.
- Consider filing a complaint with the FDA if no response is received.
How to prevent similar issues
- Ensure medical devices have up-to-date software before use.
- Regularly check for any recalls or safety notifications from manufacturers.
- Consult with peers about industry best practices for equipment safety.
Documentation advice
Keep records of all communications with the manufacturer, including emails and letters, as well as any relevant receipts or purchase confirmations.
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Product Details
The recalled product is the Da Vinci 5 Console, model number 380730. It was sold in Louisiana, Massachusetts, New York, Pennsylvania, Texas, and Virginia. The console is used for minimally invasive surgery.
Key Facts
- Recall date: November 17, 2025
- Quantity recalled: 12 units
- Distribution states: LA, MA, NY, PA, TX, VA
- Hazard classification: Class II
- Manufacturer: Intuitive Surgical, Inc.
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Safety Guide
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