Reported May 13, 2026 · Ongoing
Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000;…
Intuitive Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd · Sunnyvale, CA · 94086-5304
Is this the product you have?
- Brand NameDa
- Vinci X and Da Vinci Xi Product Nameda Vinci X
- Xi Surgical System Model/Catalog NumberIS4000
- IS4200 Software VersionN/A
- Product Descriptionhe da Vinci Xi, X Surgical systems
- each consist of three main componentsthe 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
- ComponentThe affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument
- Lot codes and dates
- Lot CodeUDI: 00886874114216
- FDA Medical Device Listing NumberD531324 See
- attachment Affected Product List UDI00886874114216
- FDA Medical Device Listing NumberD295931 See attachment Affected Product List
- Amount recalled
- 2781
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
This product could cause temporary or reversible health problems — stop using it.
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