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 | There is potential for the sterility of the product to be compromised. |
| Product | Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10. The intended use of the Tip Cover Accessory is to provide dielectric insulation over a section of the Monopolar Curved Scissor instrument so that RF energy is only available at the scissor blades. The Monopolar Curved Scissors are intended for endoscopic manipulation of tissue, including: cutting, blunt and sharp dissection, electrocautery. This accessory is to be used with the Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci, da Vinci S and da Vinci Si Surgical Systems Model… |
| Quantity | 11,121 Boxes |
| Distribution | Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Canada, and Lebanon |
| Initiated | 2012-08-09 |
| Classified | 2012-09-10 |
| Terminated | 2012-12-31 |
| Recall number | Z-2339-2012 |
| 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-2339-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62807/
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