Use caution Medical device recall · FDA · Published November 7, 2025

Da Vinci Surgical System: Software Error May Cause Instrument Failure

Intuitive Surgical recalls Da Vinci X, Xi, and 5 surgical systems due to a software error that allows malfunctioning instrument arms to remain in use, potentially leading to ball screw fatigue failure.

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

🇺🇸 FDA recall #Z-1232-2026Medical device Intuitive Surgical ›

Use caution until it’s fixed

Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that exhibit the symptoms of being bent and misaligned which is a precursor to potential ball screw fatigue failure/fraction

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Intuitive Surgical is recalling Da Vinci X, Xi, and 5 surgical systems because a software error can cause instrument arms to fail a critical diagnostic test, which might lead to ball screw fatigue failure. This could pose a risk during surgery if the arms become misaligned. Read more at govinfonow.com/recall/50708-da-vinci-surgical-system-software-error-may-cause-instrument-failure.

Source Summary by GovInfoNow · govinfonow.com/recall/50708-da-vinci-surgical-system-software-error-may-cause-instrument-failure · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1232-2026

Cite this page

“Da Vinci Surgical System: Software Error May Cause Instrument Failure.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/50708-da-vinci-surgical-system-software-error-may-cause-instrument-failure. Based on FDA recall #Z-1232-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1232-2026%22&limit=1).

The FDA announced on Nov. 7, 2025, that Intuitive Surgical is recalling the da Vinci X, Xi, and da Vinci 5 surgical systems due to a software error allowing instruments with bent ball screws to remain in use. The agency issued recall number Z-1232-2026 for the Class II device.

How to tell if you have it

Brand: Da Vinci
Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System
Model/Catalog Number: IS4000; IS4200; IS5000
Affected Component: 380647-xx, USM
Lot Code: UDI: 00886874114216
FDA Medical Device Listing Number: D531324
Affected Product List: UDI: 00886874114216 FDA Medical Device Listing Number: D295931
Affected Product List: UDI: 00886574119747 FDA Medical Device Listing Number: D531324

The hazard

According to the FDA, a software implementation error allowed instrument arms that failed an important diagnostic test to remain in clinical use. This test was designed to detect Universal Surgical Manipulator insertion axis ball screws exhibiting symptoms of being bent and misaligned, which is a precursor to potential ball screw fatigue failure or fracture.

Context

GovInfoNow's records show Intuitive Surgical has issued 53 other recalls since June 1, 2017. Recent brand recalls include the April 24, 2026, Da Vinci 5 dV5 Tower NIR Handheld Camera Recall for unintentional activation and the April 22, 2026, Intuitive Surgical Da Vinci Surgical System Recall regarding E-brake pin risk. Other recent recalls of similar products include the Mazor X Robotic System Software Errors Risk Incorrect Spinal Surgery (Dec. 10, 2025), Think Surgical TMINI Tracking Arrays: Risk of Misalignment Due to Loose Knob (May 8, 2026), and Olympus HX-400U-30 Ligating Device Recall: Risk of Unintentional Loop Fixation (Oct. 30, 2025).

How to tell if you have this one

Check if your Da Vinci system has USM serial numbers listed in the provided recall notice (e.g., 402229 SK0835 for Da Vinci Xi). The affected models are Da Vinci X, Xi, and 5 surgical systems with specific serial numbers.

Brand
Intuitive Surgical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check System Serial Numbers
Review the USM serial numbers listed in the recall notice to confirm if your system is affected.
Contact Manufacturer
Reach out to Intuitive Surgical for guidance on the next steps if your system is affected.

Where it went and when

Where it was distributed

Distributed in 30 states, and outside the U.S.

FDA distribution: “U.S.: AL, AR, CA, CO, CT, FL, ID, IL, IN, KS, KY, MD, MI, MN, MS, MO, NC, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI. O.U.S.: Austria, Brazil, China, France, Germany, Greece, India, Italy, Japan, Lebanon, Netherlands, South…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arkansas, California, Colorado, Connecticut, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.

Recall timeline

FDA published this recall 3 months after the firm started it.

Nov 7, 2025Firm started the recall
Feb 2, 2026FDA classified it Class II
Feb 11, 2026Published in FDA’s Enforcement Report

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

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Link to this recall

<a href="https://govinfonow.com/recall/50708-da-vinci-surgical-system-software-error-may-cause-instrument-failure">Da Vinci Surgical System: Software Error May Cause Instrument Failure (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-1232-2026 (November 7, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1232-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.