Use cautionMedical device recall · FDA · Published April 2, 2026
Da Vinci X and Xi Surgical Systems Recall: Risk of Broken Manipulator Screws
Intuitive Surgical recalls Da Vinci X and Xi surgical systems with model IS4000/IS4200 due to potential broken screws in manipulator arms, which could cause injury during surgery.
Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
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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 and Xi surgical systems with model numbers IS4000 and IS4200 because screws in the manipulator arms might break. This could lead to injury during surgery if the robotic arms malfunction. Read more at govinfonow.com/recall/49561-da-vinci-x-and-xi-surgical-systems-recall-risk-of.
“Da Vinci X and Xi Surgical Systems Recall: Risk of Broken Manipulator Screws.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49561-da-vinci-x-and-xi-surgical-systems-recall-risk-of. Based on FDA recall #Z-2046-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2046-2026%22&limit=1).
The FDA announced on April 2, 2026, that Intuitive Surgical, Inc. is recalling the da Vinci X and Xi Surgical Systems (models IS4000, IS4200) due to manipulator screws susceptible to breaking. This Class II recall affects 2,781 units distributed worldwide.
How to tell if you have it
Brand: Intuitive Surgical
Product Names: da Vinci X, Xi Surgical System
Model/Catalog Numbers: IS4000, IS4200
Lot Code/UDI: 00886874114216
FDA Medical Device Listing Number: D531324, D295931
Units Affected: 2,781
The hazard
The recall is due to manipulator screws within the arm sub-assembly that may be susceptible to breaking. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Intuitive Surgical, Inc. has 53 other recalls on record since June 1, 2017. Other recent recalls of similar products include the Da Vinci 5 dV5 Tower NIR Handheld Camera Recall (April 24, 2026), the Intuitive Surgical Da Vinci Surgical System Recall (April 22, 2026), and the Intuitive 8 mm SureForm 30 Gray Reloads recall (March 11, 2026). Other recent recalls of similar products include the Olympus HX-400U-30 Ligating Device Recall (October 30, 2025), the Olympus PK Cutting Forceps Recall (February 25, 2026), and the Acumed Hexalob Screw Recall (May 28, 2026).
How to tell if you have this one
Check for model numbers IS4000 or IS4200 on the Da Vinci X or Xi surgical systems. The affected part has a specific part number 380647-xx for the Universal Surgical Manipulator.
Brand
Intuitive Surgical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check for Model Number
Look for model numbers IS4000 or IS4200 on the surgical system to determine if it is affected.
Contact Manufacturer
Reach out to Intuitive Surgical directly for guidance on next steps if the system is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 48 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-2046-2026 (April 2, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2046-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.