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 | Potential for the sheath tip on the biopsy needle to separate from the sheath shaft. |
| Product | Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978 |
| Quantity | 1625 units |
| Distribution | US: AZ, AR, CA, CO, DC, FL, GA, IL, IN, IO, MD, MA, MI, MN, MO, NV, NJ, NY, NC, OH, OK, PA, TN, TX, UT, VA, WA OUS: China |
| Initiated | 2021-08-06 |
| Classified | 2021-10-13 |
| Terminated | 2024-05-17 |
| Recall number | Z-0106-2022 |
| 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-0106-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88524/
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