FDA recall Z-0970-2024

Product

Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25

Reason for recall

Reason for the voluntary recall is residue was identified on the two forceps tips of a customer in Korea. The residue is associated with one lot of forceps tips which were utilized in two lots of ACTU8 Adaptive Forceps Tips occurring in 0.25% of those lots.

Distribution

Worldwide - US Nationwide distribution in the states of OH, WA, MN, MI, IA and the country of Republic of Korea

Key facts

Status

Terminated

Initiation date

2023-12-18

Report date

2024-02-07

Termination date

2024-04-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Charles, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0970-2024