Intuitive Surgical Da Vinci Needle Driver Recall: Risk of Uncontrolled Movement
Intuitive Surgical recalls Da Vinci Single-Site Wristed Needle Driver REF 478115 (5mm) due to potential dislodgement or breakage causing uncontrolled movement. Affected units have specific serial numbers.
Use caution until it’s fixed
There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.
Contact the company
What happened, in plain English
Intuitive Surgical is recalling a specific model of Da Vinci surgical needle driver because it can become dislodged or broken, leading to uncontrolled movement during surgery. This poses a risk to patient safety and requires immediate attention from users. Read more at govinfonow.com/recall/57141-intuitive-surgical-da-vinci-needle-driver-recall-risk-of-uncontrolled.
Source Summary by GovInfoNow · govinfonow.com/recall/57141-intuitive-surgical-da-vinci-needle-driver-recall-risk-of-uncontrolled · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0406-2024
Cite this page
“Intuitive Surgical Da Vinci Needle Driver Recall: Risk of Uncontrolled Movement.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57141-intuitive-surgical-da-vinci-needle-driver-recall-risk-of-uncontrolled. Based on FDA recall #Z-0406-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0406-2024%22&limit=1).
Why it’s dangerous
The needle drive can become dislodged or broken during use, causing uncontrolled movement. This could lead to unintended tissue damage or complications during surgical procedures.
Who’s affected
Surgical teams using the Da Vinci Single-Site Wristed Needle Driver REF 478115 (5mm) are affected. Surgeons and surgical staff who have the specific serial numbers listed are most at risk.
How to tell if you have this one
Check for the specific serial numbers listed in the recall notice: T10220412, T10220420, T10220426, T10220503, T10220518, T10220629, T10220715, T10220721, T10220811, T10220819, T10220901, T10220909, T10220920, T10220923, T10220928, T10221101, T10221109, T10230207, T11221109.
- Brand
Intuitive Surgical- Category
Medical device
What to do — step by step
Check Serial Numbers
Compare your device's serial number to the list provided in the recall notice.
Where it went and when
Where it was distributed
Distributed in 13 states and Puerto Rico, and outside the U.S.
FDA distribution: “US: IL, FL, ID, SC, MI, TX, TN, NY, OR, CO, CA, MS, NJ, Puerto Rico OUS: South Korea” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Colorado, Florida, Idaho, Illinois, Michigan, Mississippi, New Jersey, New York, Oregon, Puerto Rico, South Carolina, Tennessee, Texas.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0406-2024 (October 6, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0406-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.