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 | Terminated |
| Reason | Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery. |
| Product | da Vinci X Surgical System |
| Quantity | 74 USMs containing affected rotors |
| Distribution | U.S.: CA, MD, NY, VA, IL, MI, DE, TX, FL, NJ, MA, KY and OH. O.U.S.: Australia, France, Germany and Japan. |
| Initiated | 2018-11-21 |
| Classified | 2020-05-11 |
| Terminated | 2022-05-31 |
| Recall number | Z-1961-2020 |
| 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-1961-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84023/
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