Intuitive Surgical, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0249-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.

Product Classification:

Class II

Date Initiated: June 4, 2018

Date Posted: November 6, 2019

Recall Number: Z-0249-2020

Event ID: 81073

Reason for Recall:

The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be introduced into the patient with irrigation.

Status: Ongoing

Product Quantity: 3108 units (518 boxes of 6 units)

Code Information:

Lots: T10180226 and onward; Part Numbers: 480299-04 (UDI 00886874114810)

Distribution Pattern:

Worldwide distribution. US nationwide, Australia, Italy, Switzerland, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated