Intuitive Surgical, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0275-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the system and its primary function is to support the instrument arms and camera arm. The X/Xi Instrument Arm Drape is intended to be used with the instrument arms of the PC as a sterile barrier during clinical procedures, and makes the instrument arms sterile and suitable for surgery. X/Xi Instrument Arm Drapes are sterile unless the package is opened or damaged, and are indicated for a single use. The drapes are placed onto the instrument arms by two users (one sterile and one non-sterile)in tandem, with the non-sterile user leading the placement via drape cuff pockets.

Product Classification:

Class II

Date Initiated: September 21, 2021

Date Posted: December 1, 2021

Recall Number: Z-0275-2022

Event ID: 88783

Reason for Recall:

Incorrect expiration date on its package labeling (shipper box and inner carton label).

Status: Terminated

Product Quantity: 1,740 drapes (87 bobes)

Code Information:

Part number: 470015-07; Lot number: DM4210309; REF: 470015; UDI # 00886874112199.

Distribution Pattern:

Worldwide distribution - U.S. Nationwide distribution in the states of AL, CA, GA, IL, FL, CO, TX, MO, OH, MA, WI, NC, LA, UT and the country of South Korea.

Voluntary or Mandated:

Voluntary: Firm initiated