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Lower risk Medical device recall · FDA · Published April 1, 2019

Intuitive Surgical da Vinci SP: Rare vibration risk during specific use

Intuitive Surgical recalls da Vinci SP surgical systems with specific serial numbers due to rare vibration risk when using Adjust Mode near vertical position limit and sustained force on hand controls.

🇺🇸 FDA recall #Z-2260-2020Medical deviceIntuitive Surgical ›
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Recalling firmIntuitive Surgical, Inc.1266 Kifer Rd Bldg 101 · Sunnyvale, CA 94086-5304
✎ GovInfoNow plain-language explainer

Intuitive Surgical is recalling certain da Vinci SP surgical systems because a software issue may cause instrument vibration under very specific, rare conditions. This could theoretically cause minor discomfort but not serious injury in normal use. Read more at govinfonow.com/recall/68517-intuitive-surgical-da-vinci-sp-rare-vibration-risk-during-specific.

Source Summary by GovInfoNow · govinfonow.com/recall/68517-intuitive-surgical-da-vinci-sp-rare-vibration-risk-during-specific · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2260-2020

Cite this page

“Intuitive Surgical da Vinci SP: Rare vibration risk during specific use.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68517-intuitive-surgical-da-vinci-sp-rare-vibration-risk-during-specific. Based on FDA recall #Z-2260-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2260-2020%22&limit=1).

The FDA announced on April 1, 2019, that Intuitive Surgical, Inc. is recalling its da Vinci SP surgical system due to a software anomaly that may trigger mechanical vibration of instrument tips and the endoscope. The agency issued recall number Z-2260-2020 for the Class II device.

How to tell if you have it

  • Brand: Intuitive Surgical
  • Product: da Vinci SP surgical system
  • Serial Numbers: SP0022, SP0031, SP0023, SP0032, SP0024, SP0034, SP0025, SP0035, SP0026, SP0036, SP0027, SP0037, SP0028, SP0038, SP0029, SP0039, SP0030

The hazard

The da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has the potential to occur only under extremely rare specific conditions: when the user is activating Adjust Mode, the instrument Arm is near its vertical position limit, and the user is applying sustained force against the hand control haptic feedback.

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 Da Vinci 5 dV5 Tower NIR Handheld Camera Recall (April 24, 2026), Intuitive Surgical Da Vinci Surgical System Recall (April 22, 2026), and Da Vinci X and Xi Surgical Systems Recall (April 2, 2026).

How to tell if you have this one

Check if your da Vinci SP system has a serial number from the list: SP0022, SP0031, SP0023, SP0032, SP0024, SP0034, SP0025, SP0035, SP0026, SP0036, SP0027, SP0037, SP0028, SP0038, SP0029, SP0039, SP0030.

  • Brand
    Intuitive Surgical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Number

    Verify your da Vinci SP system's serial number against the list of affected numbers provided in the recall notice.

Where it went and when

Where it was distributed

Distributed in 10 states, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: not listedWIMichigan: not listedMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: yesORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: yesOHPennsylvania: not listedPANew Jersey: yesNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: yesMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: yesTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: yesALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: not listedFL

FDA distribution: “U.S.: OH, PN, NY, MN, TN, TX, OR, IL, MD, NJ, AL. O.U.S.: South Korea” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Illinois, Maryland, Minnesota, New Jersey, New York, Ohio, Oregon, Tennessee, Texas.

Recall timeline

FDA terminated this recall 2.7 years after the firm started it.

1. Firm started the recall: Apr 1, 201912. FDA classified it Class II: Jun 3, 202023. Published in FDA’s Enforcement Report: Jun 10, 202034. FDA terminated the recall: Dec 16, 2021420192021
  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-2260-2020 (April 1, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2260-2020 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