Medical Device Recall: 8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retractio
Intuitive Surgical, Inc. · December 19, 2024
Reason for Recall
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
Product Description
8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.
Distribution
U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WI, and WY. The countries of Canada, Austria, Belgium, Denmark, Finland, France, French Guiana, Germany, Guadeloupe, Ireland, Luxembourg, Martinique, Monaco, Netherlands, Norway, Reunion, Sweden, Switzerland, United Kingdom, India, Japan, South Korea, Taiwan, Brazil, Argentina, Australia, Bulgaria, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Ecuador, Greece, Hong Kong, Hungary, Iceland, Israel, Italy, Kuwait, Lebanon, Malaysia, Malta, Mexico, New Zealand, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Thailand, Turkey, United Arab Emirates, Venezuela, Vietnam.
States Affected
NATIONWIDE
Quantity Affected
33,219
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0923-2025
Status: ongoing
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