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Recall Observatory FDA recall evidence

Device product

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

Z-0970-2024

December 18, 2023

Class II

Product summary

Firm
Vortex Surgical Inc.
Event
Event 93725
Status
Terminated
Classification
Class II
Quantity
800 devices
Official record key
device-enforcement:Z-0970-2024

Official wording

Reason: 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.

Code information: UDI/DI 00810123481132, Lot Numbers 2212002 and 2212020

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.