Intuitive Surgical, Inc.: Device Recall
Recall #Z-0923-2025 · 12/19/2024
Recall Details
- Recall Number
- Z-0923-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Intuitive Surgical, Inc.
- Status
- Ongoing
- Date Initiated
- 12/19/2024
- Location
- Sunnyvale, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33,219
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 Pattern
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.
Other Recalls by Intuitive Surgical, Inc.
- Class II: Risk 12/15/2025
- Class II: Risk 12/04/2025
- Class II: Risk 11/07/2025
- Class II: Risk 02/26/2025
- Class II: Risk 12/19/2024