Recall archive / FDA device enforcement
DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440 — FDA record Z-1210-2022
Reported completed
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 3, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440
- Reason
- Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
- Classification
- Class II
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 7,995 boxes (or 47,972 individual units ; 6 instruments/box)* The total amount will continue to grow until updated user documentation is distributed
- Agency-reported status
- Completed
- Source record identifier
- Z-1210-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI: 00886874117309. All lots |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jun 8, 2022
- Recall initiation date
- Mar 3, 2022
- Center classification date
- May 31, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.