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Use caution Medical device recall · FDA · Published April 22, 2026

Intuitive Surgical Da Vinci Surgical System Recall: E-Brake Pin Risk

Intuitive Surgical recalls Da Vinci surgical systems with specific part numbers due to potential E-brake pin failure causing uncontrolled motion and patient injury.

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

🇺🇸 FDA recall #Z-2521-2026Medical deviceIntuitive Surgical ›
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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 surgical systems with part number 380601 that may have a defective E-brake retainer pin. If the system's structural column fails, the pin could prevent the E-brake from engaging, leading to uncontrolled motion and potential patient injury. Read more at govinfonow.com/recall/49400-intuitive-surgical-da-vinci-surgical-system-recall-e-brake-pin.

Source Summary by GovInfoNow · govinfonow.com/recall/49400-intuitive-surgical-da-vinci-surgical-system-recall-e-brake-pin · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2521-2026

Cite this page

“Intuitive Surgical Da Vinci Surgical System Recall: E-Brake Pin Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49400-intuitive-surgical-da-vinci-surgical-system-recall-e-brake-pin. Based on FDA recall #Z-2521-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2521-2026%22&limit=1).

The FDA announced on April 22, 2026, that Intuitive Surgical, Inc. is recalling Da Vinci ASSY, PSS, SP1098 components due to a potential E-brake retainer pin issue that may cause uncontrolled motion and patient injury. The agency classified the Class II recall as voluntary.

How to tell if you have it

  • Brand: Intuitive Surgical
  • Product: Da Vinci ASSY, PSS, SP1098
  • Part Number: 380601
  • UDI: 00886874114605
  • Units affected: 454

The hazard

The operative components may be distributed with an E-brake retainer pin that prevents E-brake engagement during a structural column failure, potentially resulting in uncontrolled motion. If the pin moves or backs out, it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury, crushing injury, or bleeding.

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), Da Vinci X and Xi Surgical Systems Recall (April 2, 2026), and Intuitive 8 mm SureForm 30 Gray Reloads Recall (March 11, 2026). Other recent recalls of similar products include Vortex Surgical TID Pharos Illuminated Depressor Recall (December 16, 2025), Synthes 2.4V TAP CORTEX SCREW Recall (February 25, 2026), and Olympus HX-400U-30 Ligating Device Recall (October 30, 2025).

How to tell if you have this one

Check if your Da Vinci surgical system has part number 380601. The serial numbers listed in the recall include many specific numbers starting with 605408, 606848, and others. The UDI (Unique Device Identifier) is 00886874114605.

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

What to do — step by step

  1. Check System Serial Number

    Compare your Da Vinci surgical system's serial number against the list of affected serial numbers provided in the recall.

  2. Contact Manufacturer

    Reach out to Intuitive Surgical directly for assistance with the recall process.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 38 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide - US Nationwide distribution including in the states of CA, GA, OH, PA, NY, MN, TN, OR, IL, MD, NJ, AL, NV, TX, FL, LA, CT, NC, AZ, IA, MO, WA, MI, WV, WI, KY, KS, VA, OK, MA, IN, CO, SC, SD, MS, NH, UT, ME and the countries of…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Apr 22, 202612. FDA classified it Class II: Jun 22, 202623. Published in FDA’s Enforcement Report: Jul 1, 202632026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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-2521-2026 (April 22, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2521-2026 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.
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