Reported Feb 7, 2024 · Terminated
Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
Vortex Surgical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Vortex Surgical Inc. · 4 Research Park Dr Ste 124 · Saint Charles, MO · 63304-5639
Is this the product you have?
Vortex Surgical ACTU8 FORCEPS25 GAADAPTIVEREF VS0740.25
- Lot codes and dates
UDI/DI 00810123481132Lot Numbers 2212002 and 2212020
- Amount recalled
- 800 devices
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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