HIGHFDA DEVICE

Intuitive Surgical Recalls da Vinci 5 Display Over High Injury Risk

Intuitive Surgical recalled 47 da Vinci 5 Surgeon Console Viewer Displays on December 30, 2025. The devices may lose display functionality, risking surgical injury. Healthcare providers should stop using the consoles immediately and follow recall instructions.

Official notice
Intuitive SurgicalHealth & Personal CareMedical DevicesUDI: 00886874119747Serial: SQ0326SQ0336

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
December 30, 2025
Status
ACTIVE
Severity
8/10

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

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 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.

  1. Recall announced

    December 30, 2025

  2. Reported by FDA DEVICE

    February 18, 2026

  3. RecallRadar source check

    February 25, 2026

  4. 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Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization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

  1. Check the model number against the recall list.
  2. Verify serial numbers provided in the recall notice.
  3. 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.

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

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

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
UDI: 00886874119747
Serial: SQ0326
SQ0336
SQ0341
SQ0345
+15 more
Affected States
ALL
Report Date
February 18, 2026
Recall Status
ACTIVE

Related Recalls