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Lower risk Medical device recall · FDA · Published May 12, 2025

Intuitive Surgical da Vinci SP Instrument Arm Drape Recall: Risk of Procedure Delay

Intuitive Surgical recalls da Vinci SP Instrument Arm Drape, SP, 1-PACK (Part Numbers 430013-13, 430013-15) due to potential detachment of drapes causing procedure delays. Affected units sold with specific lot numbers.

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

🇺🇸 FDA recall #Z-2722-2026Medical 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 SP Instrument Arm Drapes that may detach during surgery, potentially causing procedure delays or requiring a switch to a different surgical method. This recall affects specific model numbers and lot batches sold to hospitals and surgical centers. Read more at govinfonow.com/recall/52310-intuitive-surgical-da-vinci-sp-instrument-arm-drape-recall-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/52310-intuitive-surgical-da-vinci-sp-instrument-arm-drape-recall-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2722-2026

Cite this page

“Intuitive Surgical da Vinci SP Instrument Arm Drape Recall: Risk of Procedure Delay.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52310-intuitive-surgical-da-vinci-sp-instrument-arm-drape-recall-risk. Based on FDA recall #Z-2722-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2722-2026%22&limit=1).

The FDA announced on May 12, 2025, that Intuitive Surgical, Inc. is recalling da Vinci SP Instrument Arm Drape products due to a hazard where drapes may detach from the instrument arm. This issue may expose a section of the instrument arm, potentially resulting in procedure delay or conversion to an alternate minimally invasive approach. The agency classified this as a Class II recall.

How to tell if you have it

  • Brand: Intuitive Surgical
  • Product: da Vinci SP Instrument Arm Drape, SP, 1-PACK
  • Part Numbers: 430013-13, 430013-15
  • Lot Codes: 3074LA0500, 1124LA0200, 2124LA0400, 1134LA0700, 1144LA0500, 7154LA0200, 6164LA0800, 1084LA0300, 3164LAA800, 4084LA0500, 4124LA0600, 1274LA0500, 2294LA0200, 1274LA0400, 4284LA0800, 6324LA0200, 1324LA0300, 4154LA0400, 2284LA0100, 4144LA1300, 3324LA0500, 2354LA0500, 7144LA0500, 4294LA0700, 3374LA0400, 5264LA0700, 3224LA0500, 3424LA0200, 1394LA0100
  • Units Affected: 11,113

The hazard

The da Vinci SP Instrument Arm Drape may detach from the instrument arm due to an issue involving the drape rings located at the top of the product. This detachment may expose a section of the instrument arm, which may result in procedure delay or conversion to an alternate minimally invasive approach.

Context

GovInfoNow's records show Intuitive Surgical, Inc. has 53 other recalls on record since June 1, 2017. Recent recalls include a Da Vinci 5 dV5 Tower NIR Handheld Camera recall on April 24, 2026, for unintentional activation during workflow transitions and an Intuitive Surgical Da Vinci Surgical System recall on April 22, 2026, regarding E-brake pin risk. Other recent recalls of similar products include a Medline Surgical Drapes Recall on January 28, 2026, for fabric delamination risk, an Olympus HX-400U-30 Ligating Device Recall on October 30, 2025, for unintentional loop fixation risk, and another Medline Surgical Drapes Recall on January 7, 2026, for sterility risk from calibration issues.

How to tell if you have this one

Check for the product name 'da Vinci SP Instrument Arm Drape, SP, 1-PACK' with part numbers 430013-13 or 430013-15. Affected units have specific lot numbers listed in the recall notice.

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

What to do — step by step

  1. Check Product Details

    Identify the part numbers and lot numbers listed in the recall notice to confirm if your drape is affected.

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: nationwideNHWashington: 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: named in the noticeNEMissouri: 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 in the states of NJ, OR, NY, FL, AL, SD, TX, VA, WV, PA, CA, WA, CT, MA, IL, OK, OH, MI, NC, MO, KY, WI, AZ, CO, GA, MD, SC, IN, NV, TN, MS, KS, IA, UT, MN, LA, NE, ME and the countries of Germany,…” 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, Nebraska, Nevada, 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 14 months after the firm started it.

1. Firm started the recall: May 12, 202512. FDA classified it Class II: Jul 10, 202623. Published in FDA’s Enforcement Report: Jul 22, 2026320252026
  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-2722-2026 (May 12, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2722-2026 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.
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