FDA-Device2026-07-22Class IIPACKAGING DEFECT

Intuitive Surgical da Vinci SP Instrument Arm Drape recalled for detachment risk

OTHERNationwide distributionMedical devices

What this means

Arm drapes used with Intuitive Surgical's da Vinci SP robotic surgical system may detach from the instrument arm due to a defect in the drape rings at the top of the product. If a drape detaches during surgery, it can expose part of the instrument arm and may delay the procedure or require switching to an alternative surgical approach.

Check if your facility uses da Vinci SP Instrument Arm Drapes with part numbers 430013-13 or 430013-15 and the affected lot numbers listed in this recall.
Contact Intuitive Surgical or your equipment representative for instructions on inspection, replacement, or remediation.
Do not use drapes showing signs of loose or damaged rings.

The agency's original wording

Hazard

Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result in procedure delay or conversion to an alternate minimally invasive approach. Retrospectively reported recall.

Intended for

Adults

Illnesses reported

None reported

Sold states

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, Sweden, United Kingdom, Italy, Belgium, Switzerland, Denmark, Japan, South Korea, Hong Kong, Taiwan, France, Ireland, Spain.

Affected count

11113

Manufactured in

1266 Kifer Rd, Sunnyvale, CA, United States

Products

da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2722-2026

More Intuitive Surgical recalls

FDA-Device2026-07-01
Intuitive Surgical Da Vinci surgical system recalled for E-brake failure risk

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