Intuitive Surgical da Vinci Xi/X Recall: Incorrect Expiration Date on Packaging
Intuitive Surgical recalls da Vinci Xi and X surgical systems (IS40:000 and IS4200) due to incorrect expiration dates on packaging, which could lead to improper use of sterile components.
Lower-risk recall
Incorrect expiration date on its package labeling (shipper box and inner carton label).
Contact the company
What happened, in plain English
Intuitive Surgical is recalling the da Vinci Xi and X surgical systems (model IS4000 and IS4200) because the packaging labels have incorrect expiration dates. This could mean the sterile instrument arm drapes might not be safe for use, potentially leading to infection risks during surgery. Read more at govinfonow.com/recall/61786-intuitive-surgical-da-vinci-xi-x-recall-incorrect-expiration-date.
Source Summary by GovInfoNow · govinfonow.com/recall/61786-intuitive-surgical-da-vinci-xi-x-recall-incorrect-expiration-date · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0275-2022
Cite this page
“Intuitive Surgical da Vinci Xi/X Recall: Incorrect Expiration Date on Packaging.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61786-intuitive-surgical-da-vinci-xi-x-recall-incorrect-expiration-date. Based on FDA recall #Z-0275-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0275-2022%22&limit=1).
Why it’s dangerous
The instrument arm drapes are sterile and intended for single use. If the expiration date is incorrect, the drapes might not be safe for surgery, increasing the risk of infection.
Who’s affected
Surgical teams using the da Vinci Xi or X systems (model IS4000 or IS4200) are affected. The risk is highest for hospitals and surgical centers that use these systems.
How to tell if you have this one
Check for the da Vinci Xi or X surgical systems (model IS4000 or IS4200) with part number 470015-07 and lot number DM4210309.
- Brand
Intuitive Surgical- Category
Medical device
What to do — step by step
Check Expiration Date
Verify the expiration date on the package label for the instrument arm drapes (part number 470015-07).
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 14 states.
FDA distribution: “Worldwide distribution - U.S. Nationwide distribution in the states of AL, CA, GA, IL, FL, CO, TX, MO, OH, MA, WI, NC, LA, UT and the country of South Korea.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Colorado, Florida, Georgia, Illinois, Louisiana, Massachusetts, Missouri, North Carolina, Ohio, Texas, Utah, Wisconsin.
Recall timeline
FDA terminated this recall 2.3 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-0275-2022 (September 21, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0275-2022 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.