Drug recall
daVinci Harmonic ACE Curved Shears
FDA recall event 81972 · Class II · Intuitive Surgical, Inc.
Key facts
| Event ID | 81972 |
|---|---|
| Recall numbers | Z-0841-2019 |
| Recalling firm | Intuitive Surgical, Inc. |
| Product type | Devices |
| Products | daVinci Harmonic ACE Curved Shears |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Harmonic ACE Inserts may become damaged during transit. The potential damage includes pinholes and /or… |
| Initiation date | Jan 16, 2019 |
| Report date | Feb 27, 2019 |
| 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: