Quick Facts at a Glance
- Recall Date
- December 30, 2025
- Hazard Level
- HIGH
- Brand
- Intuitive Surgical
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- Intuitive Surgical
- Product type
- Robotic Surgical System Display
- Model numbers
- UDI: 00886874119747, Serial: SQ0326, SQ0336, SQ0341, SQ0345, SQ0346, SQ0356, SQ0367 +12 more
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 30, 2025
Reported by FDA DEVICE
February 18, 2026
RecallRadar source check
February 25, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality.
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: N/A
About This Product
The da Vinci 5 Viewer Display is part of a robotic-assisted surgical system used in minimally invasive surgeries. This system allows surgeons to visualize the surgical field in 3D, enhancing precision during operations.
Why This Is Dangerous
The outdated firmware may cause the display to fail, leading to loss of 3D visualization or complete display failure. This can result in surgeons inadvertently injuring patients due to the inability to see the surgical field clearly.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall poses a significant risk to patient safety during surgeries, creating urgency for healthcare providers to remove affected devices from use and seek alternatives.
Practical Guidance
How to identify if yours is affected
- Check the model number against the recall list.
- Verify serial numbers provided in the recall notice.
- Contact your healthcare provider for assistance.
Where to find product info
The model and serial numbers can typically be found on the back or bottom of the device.
What timeline to expect
Expect 4-6 weeks for refund processing after submitting your recall request.
If the manufacturer is unresponsive
- Document your communications with the company.
- Follow up with a phone call or email.
- Consider filing a complaint with the FDA if there is no response.
How to prevent similar issues
- Ensure future devices have up-to-date firmware before use.
- Regularly check for recalls or safety notices on medical devices.
- Consult with healthcare providers regarding device safety.
Documentation advice
Keep copies of all correspondence related to the recall, including emails and phone calls, as well as any receipts.
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Product Details
The recall involves 47 units of the da Vinci 5 Surgeon Console Viewer Display, Part Number: 380730-45. These devices were distributed nationwide across multiple states including California and Texas.
Key Facts
- Potential for display loss
- Injury risk during surgery
- Stop using immediately
- Contact manufacturer for instructions
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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