Intuitive Surgical, Inc. recalls 8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide…

Recall date

December 19, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0924-2025

FDA classification

Class II

Brand / firm

Intuitive Surgical, Inc.

Sold / distributed

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 Canad…

Why it was recalled

Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

8MM, Small Graptor REF 470318 Is a grasping retractor 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.