Intuitive Surgical, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2675-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).

Product Classification:

Class II

Date Initiated: July 14, 2016

Date Posted: September 7, 2016

Recall Number: Z-2675-2016

Event ID: 74811

Reason for Recall:

Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or instrument jaws not opening.

Status: Terminated

Product Quantity: 875 instruments (827 a la carte + 48 in kits) total, all models

Code Information:

All model 470298

Distribution Pattern:

Worldwide Distribution - US (nationwide) Internationally to Australia, Belgium, Denmark, France, Germany. Italy. Japan, Spain, Sweden, Switzerland, Taiwan, and Turkey,

Voluntary or Mandated:

Voluntary: Firm initiated