Drug recall
Ion Flexison Biopsy Needle, 19G, Extension Range: 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx…
FDA recall event 88524 · Class II · Intuitive Surgical, Inc.
Key facts
| Event ID | 88524 |
|---|---|
| Recall numbers | Z-0106-2022 |
| Recalling firm | Intuitive Surgical, Inc. |
| Product type | Devices |
| Products | Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for the sheath tip on the biopsy needle to separate from the sheath shaft. |
| Initiation date | Aug 6, 2021 |
| Report date | Oct 20, 2021 |
| Termination date | May 17, 2024 |
| City | Sunnyvale |
| State | CA |
| Country | United States |
| FEI number | 3001675293 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: