Intuitive Surgical da Vinci Vessel Sealer Recall: Insufficient Seal Risk
Intuitive Surgical recalls da Vinci X/Xi vessel sealers with 8mm EndoWrist instruments (REF 480: 00886874115664) due to risk of insufficient seal when excessive tissue is placed in jaws.
Use caution until it’s fixed
Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
Contact the company
What happened, in plain English
Intuitive Surgical is recalling certain da Vinci X and Xi surgical vessel sealers because placing too much tissue in the instrument jaws can cause an insufficient seal. This could lead to bleeding or other complications during surgery. Read more at govinfonow.com/recall/60994-intuitive-surgical-da-vinci-vessel-sealer-recall-insufficient-seal-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/60994-intuitive-surgical-da-vinci-vessel-sealer-recall-insufficient-seal-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1209-2022
Cite this page
“Intuitive Surgical da Vinci Vessel Sealer Recall: Insufficient Seal Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60994-intuitive-surgical-da-vinci-vessel-sealer-recall-insufficient-seal-risk. Based on FDA recall #Z-1209-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1209-2022%22&limit=1).
Why it’s dangerous
The seal can become too weak if too much tissue is placed between the instrument jaws before sealing. This may cause bleeding or tissue damage during surgery.
Who’s affected
Surgical teams using the recalled da Vinci X or Xi vessel sealers with 8mm EndoWrist instruments. Surgeons and surgical staff are most at risk during procedures.
How to tell if you have this one
Check for the model name 'VESSEL SEALER EXTEND' with 8mm EndoWrist instruments on da Vinci X or Xi systems. The unique identifier (UDI) starts with 00886874115664.
- Brand
Intuitive Surgical- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide distribution - US Nationwide and the countries/regions of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Vietnam.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1209-2022 | VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422; UDI: 00886874115664. All lots | 140,519 boxes (843,113 individual units) |
| Z-1210-2022 | DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440; UDI: 00886874117309. All lots | 7,995 boxes (or 47,972 individual units ; 6 instruments/box)* The total amount will continue to grow until updated user documentation is distributed |
What to do — step by step
Check Instrument Model
Verify the instrument model is 'VESSEL SEALER EXTEND' with 8mm EndoWrist for da Vinci X or Xi systems.
Contact Manufacturer
Reach out to Intuitive Surgical for guidance on whether the instrument is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries/regions of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Guadeloupe,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 3 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-1209-2022 (March 3, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1209-2022 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.