FDA recall Z-0146-2026

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.

Distribution

Worldwide - US Nationwide distribution in the states of CA, IL, MA, NJ, NY, PA, TX, and UT. The countries of Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand.

Key facts

Status

Ongoing

Initiation date

2025-09-04

Report date

2025-10-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Goyang, Korea (the Republic of)

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0146-2026