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Use caution Medical device recall · FDA · Published April 11, 2019

Intuitive Surgical da Vinci Xi System: High Friction in Arms Causes Resistance

Intuitive Surgical recalls da Vinci Xi surgical systems (IS4000) with high friction in universal surgical manipulators causing resistance, hesitation, and jerking during use. Affected units have specific serial numbers and UDI codes.

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

🇺🇸 FDA recall #Z-1897-2020Medical deviceIntuitive Surgical ›
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Contact the company

Recalling firmIntuitive Surgical Inc950 Kifer Rd · Sunnyvale, CA 94086-5206
✎ GovInfoNow plain-language explainer

Intuitive Surgical is recalling da Vinci Xi surgical systems (IS4000) because their universal surgical manipulators have high friction points that cause resistance, hesitation, and jerking during surgery. This could lead to unintended movements that might affect surgical precision. Read more at govinfonow.com/recall/68361-intuitive-surgical-da-vinci-xi-system-high-friction-in-arms.

Source Summary by GovInfoNow · govinfonow.com/recall/68361-intuitive-surgical-da-vinci-xi-system-high-friction-in-arms · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1897-2020

Cite this page

“Intuitive Surgical da Vinci Xi System: High Friction in Arms Causes Resistance.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68361-intuitive-surgical-da-vinci-xi-system-high-friction-in-arms. Based on FDA recall #Z-1897-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1897-2020%22&limit=1).

Intuitive Surgical, Inc. recalled da Vinci X Surgical Systems (IS4200) due to high friction points in Universal Surgical Manipulators causing jerking movements, according to the FDA on 2019-04-11.

How to tell if you have it

  • Brand: Intuitive Surgical
  • Product: da Vinci X Surgical System, IS4200
  • Serial Numbers: SL0085, SL0315, SL0317, SL0324, SL0338, SL0350, SL0351, SL0353, SL0354, SL0357, SL0369

The hazard

The hazard involves failure of Universal Surgical Manipulators due to high friction points, resulting in increased arm movement including feelings of resistance, hesitation, and jerking.

Context

GovInfoNow's records show Intuitive Surgical, Inc. has 53 other recalls on record since 2017-06-01. Other recent recalls include the Da Vinci 5 dV5 Tower NIR Handheld Camera Recall (2026-04-24) and the Intuitive Surgical Da Vinci Surgical System Recall regarding E-Brake Pin Risk (2026-04-22).

How to tell if you have this one

Check for the da Vinci Xi system (IS4000) with serial numbers including SL0085, SL0315, SL0317, SL0324, SL0338, SL0350, SL0351, SL0353, SL0354, SL0357, or SL0369. The UDI code 00886874114216 also identifies affected units.

  • Brand
    Intuitive Surgical
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Worldwide distribution - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, District of Columbia, FL, GA, IL, IN, IA, KS. MA, MI, MS, NB, NY, OH, PA, TN, TX, VA, WA and WI and the countries of Australia, Belgium, Brazil, France, Germany, India, Italy, Japan, South Korea, Spain, Sweden, and the United Kingdom.
Recall numberProduct, codes & lotsQuantity
Z-1896-2020da Vinci Xi Surgical System, IS4000 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the IS4000 system and its primary function is to support the instrument arms and camera arm. The system has four Universal Surgical Manipulators (USM) 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. There are 4 USM per da Vinci Xi surgical system.; UDI: 00886874114216 Device Listing: D215864 Serial Numbers: SK0736, SK0856, SK1318, SK1943, SK2228, SK2236, SK2239, SK2240, SK2242, SK2244, SK2248, SK2251, SK2255, SK2256, SK2259, SK2260, SK2261, SK2266, SK2269, SK2270, SK2274, SK2275, SK2281, SK2283, SK2285, SK2294, SK2295, SK2297, SK2300, SK2303, SK2304, SK2305, SK2310, SK2311, SK2312, SK2313, SK2314, SK2315, SK2317, SK2318, SK2320, SK2327, SK2329, SK2330, SK2331, SK2333, SK2341, SK2342, SK2343, SK2346, SK2348, SK2349, SK2350, SK2353, SK2355, SK2356, SK2358, SK2359, SK2360, SK2362, SK2363, SK2364, SK2365, SK2367, SK2368, SK2369, SK2370, SK2373, SK2374, SK2375, SK2383, SK2385, SK2389, SK2390, SK2393, SK2397, SK2402, SK2404, SK2405, SK2406, SK2412, SK2418, SK2420, SK2437, SK2449, SK2451, SK2452, SK2453, SK2455270 USM units on a combination of 100 unique systems
Z-1897-2020da Vinci X Surgical System, IS4200 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the IS4000 system and its primary function is to support the instrument arms and camera arm. The system has four Universal Surgical Manipulators (USM) 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. There are four USM per da Vinci X surgical system.; UDI: 00886874114216 Device Listing: D295931 Serial Numbers: SL0085, SL0315, SL0317, SL0324, SL0338, SL0350, SL0351, SL0353, SL0354, SL0357, SL0369270 USMs on a combination of 100 unique systems (4 USM per system)
Based on the official FDA remedy

What to do — step by step

  1. Check for Resistance

    If you experience resistance, hesitation, or jerking when moving the surgical arms, stop using the system immediately.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 22 states.

Alaska: named in the noticeAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: named in the noticeDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: named in the noticeMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, District of Columbia, FL, GA, IL, IN, IA, KS. MA, MI, MS, NB, NY, OH, PA, TN, TX, VA, WA and WI and the countries of Australia, Belgium,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alaska, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Massachusetts, Michigan, Mississippi, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 5 years after the firm started it.

1. Firm started the recall: Apr 11, 201912. FDA classified it Class II: May 5, 202023. Published in FDA’s Enforcement Report: May 13, 202034. FDA terminated the recall: Apr 8, 2024420192024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

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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-1897-2020 (April 11, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1897-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA