Intuitive Surgical, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2380-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.

Product Classification:

Class II

Date Initiated: April 23, 2018

Date Posted: July 18, 2018

Recall Number: Z-2380-2018

Event ID: 80318

Reason for Recall:

Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and Green Reloads that may be missing a component of the knife mechanism. Without this component, the reload knife will not move and cut tissue when the stapler is fired.

Status: Terminated

Product Quantity: 7337

Code Information:

UDI: 00886874112878. Device expiration: 10/14/2017 02/21/2020

Distribution Pattern:

U.S., foreign and government accounts. Foreign: Australia, Austria, Belgium, Brazil, Canada, China (Hong Kong), Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated