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 | Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument. |
| Product | INSTRUMENT ARM DRAPE IS2000, 20 PACK: Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems. |
| Quantity | 92390 total instrument Drapes |
| Distribution | Worldwide Distribution - US Nationwide and the countries of: Australia, Spain, India, Italy and Saudi Arabia. |
| Initiated | 2012-07-13 |
| Classified | 2012-07-27 |
| Terminated | 2013-06-12 |
| Recall number | Z-2101-2012 |
| 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-2101-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62553/
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