Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier, Model 420003
Check against the official notice below — it lists the full affected range.
Intuitive Surgical, Inc. is recalling 62,895 Da Vinci clip applier instruments used in surgical systems across three models: the Large Clip Applier (Model 420230), Medium-Large Clip Applier (Model 420327), and Small Clip Applier (Model 420003). The instruments are affected across all serial numbers. The recall was initiated because these clip appliers have the potential for unexpected motion caused by partial disengagement from the Da Vinci S/Si surgical system. The affected devices were distributed worldwide, including throughout the United States and numerous countries.
The source document does not specify what remedy or corrective action affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
Reason for recall: Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system. Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY. The countries of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, Ch Quantity: 62,895 Clip appliers Lot/code info: Model/Model Number/UDI Number Da Vinci S/Si Large Clip Applier / 420230 / 00886874111680 Da Vinci S/Si Medium-Large Clip Applier / 420327 / 00886874111826 Da Vinci S/Si Small Clip Applier / 420003 / 00886874111161 Serial Numbers: All
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.