Intuitive Surgical recalls da Vinci X and Xi Universal Surgical Manipulators over cannula mount screws that can break (FDA Z-2046-2026)
[RECALL]Apr 2, 2026 · Intuitive Surgical · da Vinci (and Ion) · South Korea
Failure Mode
RECALL
Event Date
Apr 2, 2026
Primary Entity
Intuitive Surgical
Robotic Platform
da Vinci (and Ion)
Jurisdiction / Location
South Korea
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
On April 2, 2026, Intuitive Surgical initiated a Class 2 recall (FDA Z-2046-2026) of da Vinci X and Xi Surgical System Universal Surgical Manipulators (USMs) because screws within the arm sub-assembly may be susceptible to breaking. If all six screws break, the cannula mount can separate from the USM, potentially causing imprecise or unintended instrument tip motion during surgery. Intuitive sent Urgent Medical Device Correction letters to customers.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=219087
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=219087
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Details
Incident Context & FAQ
What happened in Intuitive Surgical recalls da Vinci X and Xi Universal Surgical Manipulators over cannula mount screws that can break (FDA Z-2046-2026)?
On April 2, 2026, Intuitive Surgical initiated a Class 2 recall (FDA Z-2046-2026) of da Vinci X and Xi Surgical System Universal Surgical Manipulators (USMs) because screws within the arm sub-assembly may be susceptible to breaking. If all six screws break, the cannula mount can separate from the USM, potentially causing imprecise or unintended instrument tip motion during surgery. Intuitive sent Urgent Medical Device Correction letters to customers.
When did this incident occur?
The incident is recorded as occurring on April 2, 2026 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in Intuitive Surgical recalls da Vinci X and Xi Universal Surgical Manipulators over cannula mount screws that can break (FDA Z-2046-2026)?
da Vinci (and Ion) by Intuitive Surgical is the recorded robot involved in this incident at South Korea.
Has anyone responded to Intuitive Surgical recalls da Vinci X and Xi Universal Surgical Manipulators over cannula mount screws that can break (FDA Z-2046-2026)?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of Intuitive Surgical recalls da Vinci X and Xi Universal Surgical Manipulators over cannula mount screws that can break (FDA Z-2046-2026)?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.