Use caution Medical device recall · FDA · Published January 24, 2023

Intuitive Surgical Patient Side Cart Recall: Risk of Tissue Injury from Instrument Arm

Intuitive Surgical recalls Patient Side Carts (REF: 380620/380652) used with da Vinci X/Xi systems due to potential instrument arm failure causing tissue injury. Affected units include specific serial numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1262-2023Medical device Intuitive Surgical ›

Use caution until it’s fixed

Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled carriage movement along the insertion axis, which may cause tissue injury.

Take action

Contact the company

Recalling firmIntuitive Surgical, Inc.1266 Kifer Rd Bldg 101 · Sunnyvale, CA 94086-5304

✎ GovInfoNow plain-language explainer

Intuitive Surgical is recalling Patient Side Carts with instrument arms used in da Vinci X and Xi surgical systems. These carts may have instrument arms that could fail, causing uncontrolled movement and tissue injury during surgery. Read more at govinfonow.com/recall/59016-intuitive-surgical-patient-side-cart-recall-risk-of-tissue-injury.

Source Summary by GovInfoNow · govinfonow.com/recall/59016-intuitive-surgical-patient-side-cart-recall-risk-of-tissue-injury · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1262-2023

Cite this page

“Intuitive Surgical Patient Side Cart Recall: Risk of Tissue Injury from Instrument Arm.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59016-intuitive-surgical-patient-side-cart-recall-risk-of-tissue-injury. Based on FDA recall #Z-1262-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1262-2023%22&limit=1).

Intuitive Surgical, Inc. voluntarily recalled Patient Side Carts with instrument arms used in da Vinci surgical systems on Jan. 24, 2023, according to the FDA. The recall addresses potential insertion ballscrew failure that may cause uncontrolled carriage movement and tissue injury.

How to tell if you have it

Brand: Intuitive Surgical
Product: Patient Side Cart, REF: 380620, with instrument arms for da Vinci X Surgical System, REF: IS4200
Product: Patient Side Cart, REF: 380652, with instrument arms for da Vinci Xi Surgical System, REF: IS4000
Units affected: 9

The hazard

Preventative maintenance data identified instrument arms at risk of insertion ballscrew failure. This defect allows for uncontrolled carriage movement along the insertion axis, which may cause tissue injury.

Context

GovInfoNow's records show Intuitive Surgical has 53 other recalls on record since June 1, 2017. Recent similar recalls include the Da Vinci X and Xi Surgical Systems Recall regarding broken manipulator screws (April 2, 2026) and the Da Vinci 5 dV5 Tower NIR Handheld Camera Recall for unintentional activation (April 24, 2026). Other recent recalls of similar products include the IMRIS ORT300 Operating Room Table Recall for unintended movement risk (Aug. 6, 2026) and the Olympus HX-400U-30 Ligating Device Recall for unintentional loop fixation risk (Oct. 30, 2025).

How to tell if you have this one

Check if your Patient Side Cart has the reference numbers 380620 (for da Vinci X) or 380652 (for da Vinci Xi). Affected units include specific serial numbers listed in the recall notice.

Brand
Intuitive Surgical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Cart Serial Numbers
Look for the serial numbers listed in the recall notice: IS4200: SL0379, SL0069/ 380620/ 00886874115404/ 668080, 575093; IS4000: SK1402, SK0991, SK2332, SK0744, SK0110, SK0753/380652 / 00886874110720/ 372054, 663693, 557322, 547953, 425439, 409962

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 3 states.

FDA distribution: “Worldwide - US Nationwide distribution in the states of FL, GA, WA and the countries of United Kingdom, Germany, France” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Georgia, Washington.

Recall timeline

FDA published this recall 57 days after the firm started it.

Jan 24, 2023Firm started the recall
Mar 16, 2023FDA classified it Class II
Mar 22, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/59016-intuitive-surgical-patient-side-cart-recall-risk-of-tissue-injury">Intuitive Surgical Patient Side Cart Recall: Risk of Tissue Injury from Instrument Arm (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1262-2023 (January 24, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1262-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.