Intuitive Surgical, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1967-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.

Product Classification:

Class II

Date Initiated: May 21, 2014

Date Posted: July 9, 2014

Recall Number: Z-1967-2014

Event ID: 68472

Reason for Recall:

Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142.

Status: Terminated

Product Quantity: All distributed prior to June 2014

Code Information:

Part number 550973

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Guadeloupe, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Indonesia, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovak Republic, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela, and Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated