Recall archive / FDA device enforcement
da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11 — FDA record Z-0702-2022
Reported ongoing
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 Dec 23, 2021. 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
- da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11
- Reason
- Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, additional surgery may be required to remove the metal tip. If the procedure proceeds without the metal tip, there is potential for energy leakage, which could cause tissue damage. If the metal tip remains in the patient, adhesions may form, which may lead to bowel obstruction and chronic abdominal pain.
- Classification
- Class II
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 149,646 reducers
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0702-2022
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: 00886874112588 L10210114 L10210115 L10210122 L10210125 L10210128 L10210204 L10210205 L10210211 L10210212 L10210215 L10210216 L10210217 L10210218 L10210219 L10210225 L10210226 L10210301 L10210304 L10210305 L10210308 L10210309 L10210316 L10210317 L10210318 L10210321 L10210322 L10210513 L10210514 L10210520 L10210521 L10210527 L10210528 L10210529 L10210715 L10210716 L10210717 L10210718 L10210719 L10210720 L10210722 L10210723 L10210731 L10210801 L10210803 L10210805 L10210806 L10210807 L10210808 L10210809 L10210812 L10210813 L10210819 L10210924 L10210925 L10210926 L10210930 L11210111 L11210316 M10210330 M10210331 M10210405 M10210408 M10210409 M10210412 M10210415 M10210416 M10210422 M10210423 M10210429 M10210430 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide distribution in the states of California, Wisconsin, Virginia, Ohio, Texas, New York, Nevada, Connecticut, New Jersey, Massachusetts, Georgia, Florida, Indiana, North Carolina, Missouri, Pennsylvania, Michigan, Oregon, Kentucky, Hawaii, Tennessee, Alabama, Nebraska, Maryland, Oklahoma, Colorado, Arkansas, Arizona, Kansas, Illinois, South Carolina, Minnesota, North Dakota, Iowa, Louisiana, Washington, Delaware, Mississippi, New Mexico, District of Columbia, Idaho, New Hampshire, Rhode Island, West Virginia, South Dakota, Alaska, Maine, Utah, Montana, Vermont, Wyoming, Puerto Rico and the countries of Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Luxembourg, Martinique, Monaco, Netherlands, Norway, Poland, Qatar, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom.
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
- District of Columbia
- 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
- Mar 9, 2022
- Recall initiation date
- Dec 23, 2021
- Center classification date
- Mar 1, 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.