Intuitive Surgical, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1210-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440

Product Classification:

Class II

Date Initiated: March 3, 2022

Date Posted: June 8, 2022

Recall Number: Z-1210-2022

Event ID: 89641

Reason for Recall:

Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.

Status: Ongoing

Product 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

Code Information:

UDI: 00886874117309. All lots

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated