Drug recall
da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
FDA recall event 92418 · Class II · Intuitive Surgical, Inc.
Key facts
| Event ID | 92418 |
|---|---|
| Recall numbers | Z-2059-2023 |
| Recalling firm | Intuitive Surgical, Inc. |
| Product type | Devices |
| Products | da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be… |
| Initiation date | Jun 12, 2023 |
| Report date | Jul 12, 2023 |
| 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: