Agency classClass IIOur severity:High FDA (Devices)·Z-1896-2020·Announced 2020-05-13

Intuitive Surgical Recalls da Vinci Xi Universal Surgical Manipulators

Intuitive Surgical is recalling 270 Universal Surgical Manipulator units from da Vinci Xi systems due to high friction causing arm movement issues.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a mechanical defect that could affect surgical performance, but the source text does not report any injuries, illnesses, or deaths, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Intuitive Surgical Inc is recalling 270 Universal Surgical Manipulator (USM) units, also known as arms, used in the da Vinci Xi Surgical System (IS4000). These units are distributed worldwide, including in the United States and various international markets.

The recall is due to high friction points in the USM units, which can result in increased arm movement characterized by feelings of resistance, hesitation, and jerking. The USM units are part of the Patient Cart, which supports the instrument arms and camera arm used by surgeons to perform surgical tasks.

The affected units are installed on 100 unique systems. Specific serial numbers for the affected USM units are listed in the official recall documentation. Healthcare facilities and users should contact Intuitive Surgical for instructions on how to address the issue.

The recalled product

Product: da Vinci Xi Surgical System, IS4000 - Product Usage: The da Vinci Xi surgical system (IS4000) is made 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 IS4000 system and its…
Manufacturer: Intuitive Surgical Inc
Category: Medical Device — Surgical Robot
Hazard: mechanical-failure
unintended-movement

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

UDI: 00886874114216 Device Listing: D215864 Serial Numbers: SK0736
SK0856
SK1318
SK1943
SK2228
SK2236
SK2239
SK2240
SK2242
SK2244
SK2248
SK2251
SK2255
SK2256
SK2259
SK2260
SK2261
SK2266
SK2269
SK2270

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Intuitive Surgical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Intuitive Surgical Inc

See all →

Moderate
da Vinci SP Instrument Arm Drape may detach during surgical procedures
FDA (Devices) · 2026-07-22
Severe
Da Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
High
Da Vinci 5 tower may unintentionally activate the infrared handheld camera
FDA (Devices) · 2026-06-10
High
da Vinci X and Xi Surgical Systems Recalled for Manipulator Arm Screw Breakage
FDA (Devices) · 2026-05-13
Severe
Intuitive 8 mm SureForm 30 Gray Reloads Incomplete Staple Defect
FDA (Devices) · 2026-05-13

Same hazard · mechanical failure