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 the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement. |
| Product | Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm |
| Quantity | 317 units |
| Distribution | US: IL, FL, ID, SC, MI, TX, TN, NY, OR, CO, CA, MS, NJ, Puerto Rico OUS: South Korea |
| Initiated | 2023-10-06 |
| Classified | 2023-11-28 |
| Recall number | Z-0406-2024 |
| 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-0406-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93301/
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