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MEDICAL DEVICE RECALLMODERATE

da Vinci 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 or your local representative to coordinate the inspection and replacement of the affected arm sub-assemblies.

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

Why it was recalled

Intuitive Surgical is recalling the Universal Surgical Manipulator (USM) arm sub-assembly used in da Vinci X and Xi surgical systems. The screws within the arm sub-assembly may be susceptible to breaking during surgical procedures, which could potentially impact system performance.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Da Vinci X and Da Vinci Xi da Vinci X, Xi Surgical SystemModel/Catalog number: IS4000, IS4200

UDI-DI
00886874114216, 00886874114216
–

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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All recalls from Intuitive Surgical, Inc.

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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification