Intuitive Surgical, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1425-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The tip cover is intended to provide electrical insulation over a section of the Monopolar Curved Scissors instrument so that FR energy is only available at the scissors blades.

Product Classification:

Class II

Date Initiated: September 23, 2011

Date Posted: June 5, 2013

Recall Number: Z-1425-2013

Event ID: 65073

Reason for Recall:

Clarification of existing labeling and related cautions for the tip cover accessory of the da Vinci Surgical System.

Status: Terminated

Product Quantity: 50,000 boxes of 10 tip covers

Code Information:

Model numbers: 400180-10 and prior versions 400180-01, 400180-02, 400180-03, 400180-04, 400180-05, 400180-05, 400180-06. 400180-07, 400180-08 and 400180-09.

Distribution Pattern:

Worldwide distribution - USA Nationwide and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated