Intuitive Surgical, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1226-2015)

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:

Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number 420187-05. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used with the fourth arm of the da Vinci S Surgical System. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to stabilize the epicardial surface of the non-arrested heart during coronary artery surgery.

Product Classification:

Class II

Date Initiated: February 16, 2015

Date Posted: March 11, 2015

Recall Number: Z-1226-2015

Event ID: 70441

Reason for Recall:

There is the possibility that the Vacuum Source Tubing set for the Endo Wrist Stabilizer may have the outer pouch compromised during shipping, resulting in small pinholes which compromise the sterility of the pouches outer surface.

Status: Terminated

Product Quantity: 706 units

Code Information:

all PN 410187-05

Distribution Pattern:

US and Belgium, Brazil, Canada, China, Finland, France, Greece, India, Italy, Japan, Qatar, Russia, Saudi Arabia, South Korea, Spain, Switzerland, Taiwan, Turkey, United Kingdom

Voluntary or Mandated:

Voluntary: Firm initiated