FDA-Device2024-02-07Class II
Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
Vortex Surgical Inc.
Hazard
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.
Sold states
Worldwide - US Nationwide distribution in the states of OH, WA, MN, MI, IA and the country of Republic of Korea
Affected count
800 devices
Manufactured in
4 Research Park Dr Ste 124, Saint Charles, MO, United States
Products
Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0970-2024Don't want to check this manually?
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