Intuitive Surgical Da Vinci Xi Stapler Recall: Potential staple deployment failure
Intuitive Surgical recalls Da Vinci Xi 8mm SureForm 30 Curved-Tip Staplers due to potential staple deployment failure and device fragment generation. Affected models include specific colors and serial numbers.
Use caution until it’s fixed
Potential staple deployment failure and device fragment generation
Contact the company
What happened, in plain English
Intuitive Surgical is recalling Da Vinci Xi 8mm SureForm 30 Curved-Tip Staplers because they may fail to deploy staples properly, causing fragments to break off. This could lead to serious injury during medical procedures if the device malfunctions. Read more at govinfonow.com/recall/59938-intuitive-surgical-da-vinci-xi-stapler-recall-potential-staple-deployment.
Source Summary by GovInfoNow · govinfonow.com/recall/59938-intuitive-surgical-da-vinci-xi-stapler-recall-potential-staple-deployment · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0340-2023
Cite this page
“Intuitive Surgical Da Vinci Xi Stapler Recall: Potential staple deployment failure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59938-intuitive-surgical-da-vinci-xi-stapler-recall-potential-staple-deployment. Based on FDA recall #Z-0340-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0340-2023%22&limit=1).
Why it’s dangerous
The stapler may fail to deploy staples correctly, causing metal fragments to break off during surgery. This could lead to serious injury if fragments damage tissues or organs during the procedure.
Who’s affected
Surgical teams using the Da Vinci Xi 8mm SureForm 30 Curved-Tip Staplers for minimally invasive procedures are most at risk. Patients undergoing surgery with these devices may face complications if the stapler malfunctions.
How to tell if you have this one
Check for the model name 'Da Vinci Xi 8mm SureForm 30' with specific color codes: gray (48230M), white (48230W), or blue (48230B). The serial numbers listed in the recall include 10886874121723, 10886874121938, 10886874121921, and 10886874121914.
- Brand
Intuitive Surgical- Category
Medical device
What to do — step by step
Check Product Serial Number
Look for the serial numbers listed in the recall: 10886874121723, 10886874121938, 10886874121921, or 10886874121914.
Contact Manufacturer
Reach out to Intuitive Surgical directly for further assistance or to confirm if your device is affected.
Where it went and when
Where it was distributed
Distributed in 24 states.
FDA distribution: “U.S.: Arizona, California, Colorado, Florida, Illinois, Indiana, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Colorado, Florida, Illinois, Indiana, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.
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-0340-2023 (October 7, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0340-2023 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.