FDAFDA · Food and drugs·Recall number Z-0970-2024
Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
Published February 7, 2024 · Recall initiated: December 18, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Vortex Surgical Inc.
- Distributor
- Worldwide - US Nationwide distribution in the states of OH, WA, MN, MI, IA and the country of Republic of Korea
- Lot
- UDI/DI 00810123481132, Lot Numbers 2212002 and 2212020
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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