Intuitive Surgical daVinci X EndoWrist Stapler 45 Recall: Incorrect Wrench Interface May
Intuitive Surgical recalls daVinci X EndoWrist Stapler 45 models with serial numbers S10170630, S11170705, S10170707, S10170731 due to a potential manufacturing defect that may prevent the Stapler Release Kit Wrench from unclamping the instrument.
Use caution until it’s fixed
Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in the manufacturing process. In affected instruments, there is a possibility that the Stapler Release Kit (SRK) Wrench interface feature accessed through release hole 2 is manufactured to an incorrect dimension, which may prevent the SRK Wrench from being able to manually unclamp the instrument.
Contact the company
What happened, in plain English
Intuitive Surgical is recalling specific daVinci X EndoWrist Stapler 45 instruments that may have a manufacturing defect causing the Stapler Release Kit Wrench to not unclamp the instrument. This could lead to complications during surgery if the instrument cannot be properly released. Read more at govinfonow.com/recall/73006-intuitive-surgical-davinci-x-endowrist-stapler-45-recall-incorrect-wrench.
Source Summary by GovInfoNow · govinfonow.com/recall/73006-intuitive-surgical-davinci-x-endowrist-stapler-45-recall-incorrect-wrench · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0404-2018
Cite this page
“Intuitive Surgical daVinci X EndoWrist Stapler 45 Recall: Incorrect Wrench Interface May.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/73006-intuitive-surgical-davinci-x-endowrist-stapler-45-recall-incorrect-wrench. Based on FDA recall #Z-0404-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0404-2018%22&limit=1).
Why it’s dangerous
The Stapler Release Kit Wrench interface feature accessed through release hole 2 may be manufactured to an incorrect dimension. This could prevent the wrench from manually unclamping the instrument during surgery, potentially causing complications.
Who’s affected
Surgical teams using the daVinci X EndoWrist Stapler 45 with serial numbers S10170630, S11170705, S10170707, or S10170731 are most at risk. These instruments are used in general, thoracic, gynecologic, and urologic surgeries.
How to tell if you have this one
Check for serial numbers S10170630, S11170705, S10170707, or S10170731 on the daVinci X EndoWrist Stapler 45 instruments. These models were sold with the da Vinci Surgical System (Model IS4000) for specific surgical procedures.
- Brand
Intuitive Surgical- Category
Medical device
What to do — step by step
Check Serial Numbers
Verify if your instrument has serial numbers S10170630, S11170705, S10170707, or S10170731.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 6.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-0404-2018 (September 19, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0404-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 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.