Intuitive Surgical, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1380-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

da Vinci S Surgical System IS2000, Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

Product Classification:

Class II

Date Initiated: March 16, 2015

Date Posted: April 15, 2015

Recall Number: Z-1380-2015

Event ID: 70777

Reason for Recall:

Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

Status: Terminated

Product Quantity: 442,475 total all drape models

Code Information:

Product number 400015-03; da Vinci (Standard System) Inst. Arm Drape, 20 Pack. Lot Numbers for Cloudy/Waxy issue: ALL lot numbers Lot Numbers for Tear issue: None

Distribution Pattern:

Worldwide Distribution-Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China (including Hong Kong), Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, France, Germany, Greece, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Mauritius, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated