Medical Device Recall: da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
Intuitive Surgical, Inc. · May 12, 2025
Reason for Recall
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.
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, Sweden, United Kingdom, Italy, Belgium, Switzerland, Denmark, Japan, South Korea, Hong Kong, Taiwan, France, Ireland, Spain.
States Affected
NATIONWIDE
Quantity Affected
11113
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2722-2026
Status: ongoing
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