Intuitive Surgical, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0445-2015)

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:

8MM, SMALL GRASPING RETRACTOR ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Product Classification:

Class II

Date Initiated: November 3, 2014

Date Posted: December 3, 2014

Recall Number: Z-0445-2015

Event ID: 69638

Reason for Recall:

Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.

Status: Terminated

Product Quantity: 509 total units, all affected devices

Code Information:

Part number; 470318-04 ; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Distribution Pattern:

US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.

Voluntary or Mandated:

Voluntary: Firm initiated