Intuitive Surgical, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2171-2014)

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:

EndoWrist Stapler System User Manual Addendum and Wall Chart; The EndoWrist Stapler 45 System and EndoWrist Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model IS3000) for resection, transection and/or creation of anastomoses in General, Gynecologic and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).

Product Classification:

Class II

Date Initiated: June 2, 2014

Date Posted: August 20, 2014

Recall Number: Z-2171-2014

Event ID: 68814

Reason for Recall:

Changes were made to the Stapler EndoWrist Stapler 45 System Instruments and Accessories User Manual Addendum (550986-03) and the EndoWrist Stapler 45 Wall Chart (PN 551524-01) in which the pH range specification for the enzymatic cleaner used throughout the cleaning process was modified from pH-neutral to pH-neutral to mild alkaline (mild alkaline is defined as pHd11). Mild Alkaline enzymatic

Status: Terminated

Product Quantity: 2

Code Information:

Model number 410298-05 and 410298-06

Distribution Pattern:

Distribution to Florida and South Carolina

Voluntary or Mandated:

Voluntary: Firm initiated