Brand Name: Da Vinci Product Name: da Vinci X — Class II medical device recall Z-1232-2026
Ongoing recall by Intuitive Surgical, Inc., reported 2026-02-11, distributed in AL, AR, CA, CO, CT, FL, ID, IL…. Due to a software implementation error that allowed instruments arms failing an important diagnostic test to r
| Recall number | Z-1232-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2025-11-07 |
| Classified | 2026-02-02 |
| Reported by FDA | 2026-02-11 |
| Distributed | AL, AR, CA, CO, CT, FL, ID, IL, IN, KS, KY, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI |
| Countries outside the US | AT, BR, CH, CN, DE, ES, FR, GB, GR, IN, IT, JP, KR, LB, NL, TW |
| Quantity | 219 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00886874114216 |
| Lot numbers | 00886874114216FDA |
| Serial numbers | 10008899, 10010562, 10011023, 10012820, 10130883, 10143148, 10200891, 10201501, 10301063, 10305355, 10305783, 10340208, 10340225, 10340569, 10345076, 10345542, 10345574, 10347613, 10347621, 10397285, 10398002, 10403504, 10581505, 10591492, 10592026 and 184 more |
| Model numbers | IS4000 |
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
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1232-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.