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da Vinci X and Xi Surgical System Universal Surgical Manipulator
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MEDICAL DEVICE RECALLMODERATE

da Vinci X and Xi Surgical System Universal Surgical Manipulator

Intuitive Surgical is recalling the USM arm sub-assembly for da Vinci X and Xi systems due to a risk of internal screw breakage.

What to do

Contact Intuitive Surgical for inspection and replacement of the affected manipulator arm sub-assemblies.

Posted
Updated
Recall No.
Z-2046-2026
Agency
Firm
Intuitive Surgical, Inc.
Recall ID
98564
Status
ONGOING

Why it was recalled

Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.

How to identify it

UPC 00886874114216 00886874114216

Where it was sold

Distributed in US.

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Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification