XERF EFFECTOR 60 — Class II medical device recall Z-0146-2026
Ongoing recall by Lutronic Corporation, reported 2025-10-22, distributed nationwide. Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse e
| Recall number | Z-0146-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lutronic Corporation, Goyang, Korea (the Republic of) |
| Recall initiated | 2025-09-04 |
| Classified | 2025-10-14 |
| Reported by FDA | 2025-10-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, HK, JP, KR, PH, SG, TH, TW, VN |
| Quantity | 7,490 units |
| UPC / GTIN / UDI-DI | 08809447657752 |
| Lot numbers | MP60J25C02, MP60J25G05, MP60J25G06, MP60J25H01, MP60J25H03 |
| Model numbers | 1101210000, 1101210100, 1101210200 |
Product
XERF EFFECTOR 60. Electrosurgical unit.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0146-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.