Intuitive Surgical, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1118-2015)

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:

HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000; for use with the da Vinci Surgical System - IS2000 and IS3000. Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is used in conjunction with the da Vinci Surgical System

Product Classification:

Class II

Date Initiated: January 21, 2015

Date Posted: February 25, 2015

Recall Number: Z-1118-2015

Event ID: 70275

Reason for Recall:

Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips.

Status: Terminated

Product Quantity: 12,467 - both sizes

Code Information:

PN 400275, 420275, and 420272.

Distribution Pattern:

Worldwide Distribution -- US, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, India, Israel, Italy, Japan, Lebanon, Mexico, Monaco, Netherlands, Pakistan, Panama, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and the United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated