Class 2 Device Recall Da Vinci

• Date Initiated by Firm: November 07, 2025
• Date Posted: February 02, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1232-2026
• Recall Event ID: 98050
• 510(K)Number: K131861 K171294 K232610
• Product Classification: System, surgical, computer controlled instrument - Product Code NAY
• Product: Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinci Xi, X, and da Vinci 5 surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument
• Code Information: Lot Code: UDI: 00886874114216 FDA Medical Device Listing Number: D531324 See attachment Affected Product List UDI: 00886874114216 FDA Medical Device Listing Number: D295931 See attachment Affected Product List UDI: 00886574119747 FDA Medical Device Listing Number: D531324 See attachment Affected Product List da Vinci Xi (U.S.) USM Serial Numbers / System Serial Numbers: 402229 SK0835 766250 SK2180 797416 SK3689 674366 SK0095 453952 SK0135 10200891 RSK8057 675618 SK3649 634899 SK2504 440133 SK0682 362922 SK6006 405421 SK0449 390728 SK0389 608999 SK2328 395840 SK0523 368190 SK0837 441220 SK0909 596758 SK5711 474567 SK0075 376348 RSK8009 468435 SK1448 586220 SK5354 417890 SK2763 620604 SK2121 454704 SK1314 601085 SK4517 360714 SK2497 502409 SK0480 450881 SK1012 374877 SK2478 614195 SK1155 10012820 SK2135 685557 SK2489 575597 SK5978 432486 SK3140 624939 SK4316 357017 SK0157 448370 SK0959 432785 SK1380 552202 SK4752 801777 SK3600 598141 SK1967 653902 SK0048 791279 SK5269 392895 SK0992 423997 SK1265 10130883 SK5682 10345574 SK0756 609316 SK0756 643879 SK1802 721374 SK2851 721385 SK2851 721390 SK2851 726207 SK2851 423127 SK0159 453587 SK0159 789074 SK0159 803938 SK3632 808928 SK3632 811477 SK3632 405752 SK0886 821001 SK3749 821012 SK3749 821018 SK3749 396587 SK0448 396835 SK0448 396956 SK0448 539536 SK0448 10201501 SK2573 364250 SK2573 389078 SK2573 10581505 SK8006 10591492 SK8006 10592026 SK8006 10592897 SK8006 10397285 SK7337 10398002 SK7337 10403504 SK7337 626074 SK7337 682234 SK2552 684029 SK2552 557855 SK1374 558304 SK1374 678245 SK1374 783025 SK3579 803627 SK3579 806689 SK3579 807816 SK3579 10143148 SK2686 457566 SK2686 673397 SK2686 951895 SK4542 957596 SK4542 959481 SK4542 959484 SK4542 662812 SK2351 662935 SK2351 663327 SK2351 946051 SK4628 972693 SK4628 973277 SK4628 973278 SK4628 785070 SK3363 785071 SK3363 786266 SK3363 448204 SK0152 703938 SK0152 574265 SK0159 592288 SK1817 560902 SK1913 537160 SK1913 459654 SK1913 556989 SK3209 729789 SK3209 731745 SK3209 737618 SK3459 389462 SK4178 845962 SK4178 846972 SK4178 846947 SK4178 10008899 SK4781 10010562 SK4781 10011023 SK4781 10301063 SK6842 10305355 SK6842 10305783 SK6842 10340208 SK6866 10340225 SK6866 10340569 SK6866 10345076 SK6924 10345542 SK6924 10347613 SK6924 10347621 SK6924 da Vinci Xi (O.U.S.) 10144327 SK0241 885500 SK4083 709052 SK2651 10002413 SK4695 10531698 CX0067 441442 SK0934 435551 SK0907 10241998 SK6332 10318042 SK6759 10216387 SK6341 10217208 SK6341 392890 SK0256 10216383 SK6250 587895 SK0950 789071 SK0777 450418 SK0388 740913 SK2996 392885 SK0129 464471 SK1034 423008 SK0658 726556 SK5869 443119 SK0925 10340582 SK6917 10514694 SK7706 818737 SK3669 819530 SK3669 820601 SK3669 10060417 SK5032 10061285 SK5032 10061291 SK5032 10061294 SK5032 10222556 SK2052 421449 SK2052 10051344 SK5104 10066499 SK5104 10068969 SK5104 10068971 SK5104 10207068 SK3598 803631 SK3598 810035 SK3598 810039 SK3598 696805 SK2661 700673 SK2661 700674 SK2661 701164 SK2661 753819 SK3194 754670 SK3194 754675 SK3194 712123 SK4070 768086 SK5782 10186169 SK3114 823169 SK3114 10160467 SK3599 811473 SK3599 10205803 SK6415 10225737 SK6415 10236546 SK6415 791775 SK3494 791780 SK3494 792156 SK3494 792565 SK3494 691130 SK2666 694460 SK2666 694487 SK2666 694988 SK2666 378145 SK0124 722261 SK2839 724635 SK2839 10225711 SK6630 10233347 SK6630 10233349 SK6630 10233962 SK6630 646334 SK2249 648830 SK2249 649482 SK2249 10414903 SK3114 859539 SK2649 da Vinci X (O.U.S.) 364477 SL0052 10233342 SL1118 392675 SL0264 593091 SL0178 10168067 SL0255 686701 SL0598 686724 SL0598 689991 SL0598 704719 SL0598 da Vinci 5 (U.S.) USM Serial Numbers / System Serial Numbers: 10651060 SQ0343 da Vinci 5
• FEI Number: 3001675293
• Recalling Firm/ Manufacturer: Intuitive Surgical, Inc.; 1266 Kifer Rd; Sunnyvale CA 94086-5304
• For Additional Information Contact: Luis Dominguez Rendon; 408-523-2100
• Manufacturer Reason for Recall: Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that exhibit the symptoms of being bent and misaligned which is a precursor to potential ball screw fatigue failure/fraction
• FDA Determined Cause: Process control
• Action: On 11/07/2025 and 11/13/2025, the firm emailed "Urgent Stop Use: Product Safety Notice" letters to customers informing them to stop use of specific da Vinci Surgical Systems. In 2022 Intuitive Surgical initiated a field action related to instrument arm ball screw failures. As a result, a field test was implemented to improve detection of affected ball screw. Intuitive has become aware that this test did not alert the service technicians of pass/fail results. Customer are instructed to immediately stop using affected da Vinci Systems. Intuitive will provide a formal follow-up communication, and our representative will contact you to schedule a site visit to perform the necessary corrections. Please distribute this communication to all relevant hospital personnel (e.g., surgeons, OR directors, risk managers, etc.) who use your affected da Vinci Surgical System. For Questions, contact Customer Service at: " North and South America: (800) 876-1310, Option 3 (4 am to 5 pm PST) or mail: customerservice@intusurg.com. " Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET) or eucs@intusurg.com " South Korea: 02-3271-3200 (9 am to 6 pm KSTJ) or support.korea@intusurg.com " Japan: 0120-56-5635 or 03-5575-1362 (9 am to 6 pm JST) or csjapan@intusurg.com " India: +1-800-103-6952 (9 am to 6 pm IT) " Taiwan: +0800-86-8181 (9 am to 6 pm CT)
• Quantity in Commerce: 219
• Distribution: U.S.: AL, AR, CA, CO, CT, FL, ID, IL, IN, KS, KY, MD, MI, MN, MS, MO, NC, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI. O.U.S.: Austria, Brazil, China, France, Germany, Greece, India, Italy, Japan, Lebanon, Netherlands, South Korea, Spain, Switzerland, Taiwan and United Kingdom
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NAY