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 | There is a potential that the robotic system's instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a catheter inside a patient's airways. |
| Product | Ion Endoluminal System, REF: 380748-65 |
| Quantity | 3 units |
| Distribution | US Nationwide distribution in the states of AZ and CA. |
| Initiated | 2024-07-12 |
| Classified | 2024-08-23 |
| Recall number | Z-2720-2024 |
| 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-2720-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95046/
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