Intuitive Surgical, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2105-2012)

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:

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.

Product Classification:

Class II

Date Initiated: July 13, 2012

Date Posted: August 8, 2012

Recall Number: Z-2105-2012

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: 420291-03 Lot numbers: D120795 ,D120795A , D120805, D120815, D120875, D120885, D120885A, D120935, D120935A,D120945 D121015 D121025 D121025A D121105 D121105A D121355A

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated