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 | Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top Failure: internal tissue injuries, body wall injury or emergent conversion to open surgery, 2) Bottom failure: pinching injury to the user with no harm to the patient. |
| Product | Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098 |
| Quantity | 53 |
| Distribution | US: VA, CA, NH, FL, NY, CO, AL, KY, MD, NC, NJ, OH, SC, SD, TN, WA, WI, WV, MS, TX, KS. OUS: China, France, Japan, South Korea |
| Initiated | 2024-03-13 |
| Classified | 2024-04-11 |
| Recall number | Z-1518-2024 |
| 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-1518-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94252/
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