Intuitive Surgical, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2106-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 13, 2012

Date Posted: August 8, 2012

Recall Number: Z-2106-2012

Event ID: 62553

Reason for Recall:

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

Status: Terminated

Product Quantity: 92390 total instrument Drapes

Code Information:

Part number: 380595-02 Lot numbers: 298601, 298602, 298608, 298613, 298625, 298627, 298629.

Distribution Pattern:

Worldwide Distribution - US Nationwide and the countries of: Australia, Spain, India, Italy and Saudi Arabia.

Voluntary or Mandated:

Voluntary: Firm initiated