Intuitive Surgical, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1812-2015)

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:

Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. Intended for endoscopic manipulation of tissue, including grasping.

Product Classification:

Class II

Date Initiated: May 21, 2015

Date Posted: June 24, 2015

Recall Number: Z-1812-2015

Event ID: 71285

Reason for Recall:

The coating of the 5 mm Thoracic Grasper main tube may experience damage with the possibility of fragments of coating material dislodging and potentially falling into patient.

Status: Terminated

Product Quantity: 2,436 units

Code Information:

version 420343-01 and 420323-02, all lots

Distribution Pattern:

Worldwide Distribution -- US, Belgium, Brazil, Canada, Chile, Colombia,, Denmark, France, Germany, India, Netherlands, Panama, Singapore, South Korea, Switzerland, Taiwan, Turkey, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated