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 | Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument. |
| Product | 8MM PERMANENT CAUTERY SPATULA,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. |
| Quantity | 509 total units - all affected devices |
| Distribution | US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA. |
| Initiated | 2014-11-03 |
| Classified | 2014-11-25 |
| Terminated | 2015-02-03 |
| Recall number | Z-0437-2015 |
| 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-0437-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69638/
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