Home / Recalls / Intuitive Surgical, Inc. / Z-1210-2022

Z-1210-2022 Class II Ongoing

Recalled by Intuitive Surgical, Inc. — Sunnyvale, CA

Recall Details

Product Type
Devices
Report Date
June 8, 2022
Initiation Date
March 3, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
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

Product Description

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

Reason for Recall

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

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.

Code Information

UDI: 00886874117309. All lots

Other recalls by Intuitive Surgical, Inc.

  • Z-2046-2026 Class II — Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical S (April 2, 2026)
  • Z-1855-2026 Class I — Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230 (March 11, 2026)
  • Z-1355-2026 Class II — da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Numbe (December 30, 2025)
  • Z-1096-2026 Class II — da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2. (December 15, 2025)
  • Z-1697-2026 Class II — Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: (December 9, 2025)
  • Z-1696-2026 Class II — Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: d (December 9, 2025)
  • Z-1700-2026 Class II — Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci (December 9, 2025)
  • Z-1701-2026 Class II — Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da V (December 9, 2025)
  • Z-1699-2026 Class II — Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci (December 9, 2025)
  • Z-1698-2026 Class II — Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci (December 9, 2025)