Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X — Class II medical device recall Z-2046-2026
Ongoing recall by Intuitive Surgical, Inc., reported 2026-05-13, distributed nationwide. Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
| Recall number | Z-2046-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2026-04-02 |
| Classified | 2026-05-01 |
| Reported by FDA | 2026-05-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CN, CY, CZ, DE, DK, EC, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IN, IT, JP, KR, LU, MT, MX, MY, NL, NO, PL, PT, QA, RO, SA, SE, SG, SI, SK, TR, TW, ZA |
| Quantity | 2,781 |
| UPC / GTIN / UDI-DI | 00886874114216 |
| Lot numbers | 00886874114216FDA |
| Model numbers | IS4000 |
Product
Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X 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
Reason for recall
Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.