Drug recall
XERF EFFECTOR 60. Electrosurgical unit.
FDA recall event 97620 · Class II · Lutronic Corporation
Key facts
| Event ID | 97620 |
|---|---|
| Recall numbers | Z-0146-2026 |
| Recalling firm | Lutronic Corporation |
| Product type | Devices |
| Products | XERF EFFECTOR 60. Electrosurgical unit. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients. |
| Initiation date | Sep 4, 2025 |
| Report date | Oct 22, 2025 |
| City | Goyang |
| Country | Korea (the Republic of) |
| FEI number | 3004483538 |
At a glance
- 1–9 Products in this recall
- 1–9 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: