The Recall Desk

FDA (Devices) recall action 66918

Intuitive Surgical, Inc. recalled 2 products on 2013-12-25

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2013-12-25
Critical
0
Units
—

Why these products were recalled

Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2013-12-25

    Intuitive Surgical Recalls Mega Needle Drivers for Potential Jaw Detachment

    Intuitive Surgical is recalling Mega Needle Drivers for the da Vinci S and Si systems due to a potential risk of jaw insert detachment.

    Product
    Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation o
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2013-12-25

    Intuitive Surgical Recalls Large Needle Drivers Due to Jaw Insert Detachment Risk

    Intuitive Surgical is recalling Large Needle Drivers for the da Vinci S and Si systems because the jaw insert may detach during use.

    Product
    Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation
    Category
    Distribution
    1 state