What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision.

Has Intuitive Surgical, Inc. had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 4 total FDA actions tied to Intuitive Surgical, Inc., including 4 recalls and 0 warning letters.

FDA Class II Recall: Brand Name: Da Vinci X and Da Vinci… by Intuitive Surgical, Inc.

Key facts

Recalling firm	Intuitive Surgical, Inc.
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument
Classification	Class II
Recall number	Z-2046-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.

Key takeaway: Intuitive Surgical, Inc. recalled Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision (additional items listed in FDA's full record) on 2026-05-13. FDA classified this action as a Class II recall (recall number Z-2046-2026). Reason for recall: Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.. Recall status: Ongoing. This is a device-category FDA recall record.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Intuitive Surgical, Inc. and the affected product is described in FDA's record as: Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision (additional items listed in FDA's full record). FDA's stated reason for the recall is: Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.. The recall is tracked under FDA recall number Z-2046-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision (additional items listed in FDA's full record) -- and the recall number Z-2046-2026. If it matches, stop using or distributing it and contact Intuitive Surgical, Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

Intuitive Surgical, Inc.’s FDA history

Argus HQ has recorded 4 total FDA actions tied to Intuitive Surgical, Inc.: 0 warning letters, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

How serious is this recall?: FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
What should someone who has this product do?: Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision.
Has Intuitive Surgical, Inc. had other FDA recalls or enforcement actions?: Yes. Argus HQ has recorded 4 total FDA actions tied to Intuitive Surgical, Inc., including 4 recalls and 0 warning letters.
What is the FDA recall number for this event?: FDA recall number Z-2046-2026.

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Full FDA history for Intuitive Surgical, Inc.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). FDA Class II Recall: Brand Name: Da Vinci X and Da Vinci… by Intuitive Surgical, Inc.. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-intuitive-surgical-inc-z-2046-2026

MLA

"FDA Class II Recall: Brand Name: Da Vinci X and Da Vinci… by Intuitive Surgical, Inc.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-intuitive-surgical-inc-z-2046-2026.

Chicago

Argus HQ Research. "FDA Class II Recall: Brand Name: Da Vinci X and Da Vinci… by Intuitive Surgical, Inc.." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-intuitive-surgical-inc-z-2046-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_intuitive_surgical_inc_z_2046_2026_2026,
  title = {FDA Class II Recall: Brand Name: Da Vinci X and Da Vinci… by Intuitive Surgical, Inc.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/fda-recall-intuitive-surgical-inc-z-2046-2026},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Recalls ↗