Intuitive Surgical, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1442-2013)

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:

8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distributed by: Intuitive Surgical Sunny vale, CA The EndoWrist Monopolar Curved Scissors Instrument is a multiple-use endoscopic instrument utilizing a single use, tip cover accessory, to be used in conjunction with the Intuitive Surgical Endoscopic Instrument Control System.

Product Classification:

Class II

Date Initiated: May 8, 2013

Date Posted: June 12, 2013

Recall Number: Z-1442-2013

Event ID: 65216

Reason for Recall:

Intuitive Surgical has identified a potential for some units of the Monopolar curved Scissors version 09 and 10 instruments to develop very small cracks near the distal end. This may create a pathway for electrosurgical energy to leak to tissue and potentially cause thermal injury.

Status: Terminated

Product Quantity: ~132,441 instruments

Code Information:

Model Numbers 420179-09 and -10 and 400179-09 and -10.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated