Intuitive Surgical, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1048-2015)

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 Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Product Classification:

Class II

Date Initiated: January 15, 2015
Date Posted: February 11, 2015
Recall Number: Z-1048-2015
Event ID: 70181
Reason for Recall:

The Wall chart has been updated because it was noted that Wall Chart (PN 551524-03 Rev A) was inconsistent with the User Manual Adendum (PN 550986-07_B) with regards to neceassary sterilization dry time.

Status: Terminated
Product Quantity: 1,034
Code Information:

PN 410298-05, -06, -07, -08, -09

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated