Class II — Intuitive Surgical, Inc.
| Recalling firm | Intuitive Surgical, Inc. |
|---|---|
| Registered facility | View this company's 41 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications. |
| Product | da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200 |
| Quantity | 1,225 total USMs |
| Distribution | U.S.: Cayman Islands, Dominican Republic, Puerto Rico, United States O.U.S.: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Luxembourg, Martinique, Monaco, Netherlands, Norway, Reunion, Sweden, Switzerland, United Kingdom, India, Japan, South Korea, Taiwan, Brazil, Argentina, Australia, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Ecuador, Greece, Guadeloupe, H… |
| Initiated | 2023-02-10 |
| Classified | 2023-03-28 |
| Recall number | Z-1293-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Intuitive Surgical, Inc. (Z-1293-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91503/
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