The Recall Desk

FDA (Devices) recall action 62553

Intuitive Surgical, Inc. recalled 6 products on 2012-08-08

The FDA (Devices) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2012-08-08
Critical
0
Units
554,340

Why these products were recalled

Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–6 of 6

  • HighFDA (Devices)··2012-08-08

    Intuitive Surgical Recalls Instrument Arm Drapes Due to Adaptor Engagement Issues

    Intuitive Surgical is recalling specific lots of Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument during surgery.

    Product
    ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-08-08

    Intuitive Surgical Recalls Instrument Arm Drapes Due to Adaptor Engagement Issues

    Intuitive Surgical is recalling specific lots of Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument during surgical procedures.

    Product
    INSTRUMENT ARM DRAPE IS2000, 20 PACK: Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-08-08

    Intuitive Surgical Recalls Specific Lots of da Vinci Instrument Arm Drapes

    Intuitive Surgical is recalling specific lots of da Vinci Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument.

    Product
    KIT,DISPOSABLE ACCESSORY,3ARM,IS2000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-08-08

    Intuitive Surgical Recalls Specific Lots of da Vinci Instrument Arm Drapes

    Intuitive Surgical is recalling specific lots of da Vinci Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument.

    Product
    KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-08-08

    Intuitive Surgical Recalls Specific Lots of da Vinci Instrument Arm Drapes

    Intuitive Surgical is recalling specific lots of da Vinci Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument.

    Product
    KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-08-08

    Intuitive Surgical Recalls Specific Lots of da Vinci Instrument Arm Drapes

    Intuitive Surgical is recalling specific lots of da Vinci Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument.

    Product
    KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
    Category
    Distribution
    0 states