Reported Dec 6, 2023 · Ongoing

Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm

Intuitive Surgical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd Bldg 101 · Sunnyvale, CA · 94086-5304

Is this the product you have?

  • Da Vinci Single-Site Wristed Needle Driver
  • REF
    • 478115
    • 5 mm
Lot codes and dates
  • UDI00886874113752/
  • Serial Numbers
    • T10220412
    • T10220420
    • T10220426
    • T10220503
    • T10220518
    • T10220629
    • T10220715
    • T10220721
    • T10220811
    • T10220819
    • T10220901
    • T10220909
    • T10220920
    • T10220923
    • T10220928
    • T10221101
    • T10221109
    • T10230207
    • T11221109
Amount recalled
317 units

Where it was sold

Why it was recalled

There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:40 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.