The Recall Desk
HighFDA (Devices)·Z-0970-2024·Announced 2024-02-07

Vortex Surgical ACTU8 Forceps Recalled Due to Residue on Forceps Tips

Vortex Surgical has voluntarily recalled 800 ACTU8 FORCEPS units due to residue identified on forceps tips. The recall affects surgical instruments distributed in the US (OH, WA, MN, MI, IA) and Korea.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA recall with no reported illnesses or injuries. The residue on surgical forceps poses a risk of harm to patients during surgical use, but no adverse events have been reported.

Plain-English summary

Vortex Surgical Inc. has voluntarily recalled 800 ACTU8 FORCEPS, 25 GA, ADAPTIVE surgical forceps (UDI/DI 00810123481132, Lot Numbers 2212002 and 2212020).

Residue was identified on the tips of forceps from one customer in Korea. This residue was associated with one lot of forceps tips that were used in the manufacture of two lots of ACTU8 Adaptive Forceps. The contamination affected 0.25% of those affected lots.

The affected devices were distributed worldwide, with US distribution in Ohio, Washington, Minnesota, Michigan, and Iowa, as well as to the Republic of Korea. Consumers and healthcare providers who have received these devices should contact Vortex Surgical Inc. immediately.

The recalled product

Product
Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
Manufacturer
Vortex Surgical Inc.
Category
Medical Device — Surgical Instruments
Hazard
  • residue

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI/DI 00810123481132
  • Lot Numbers 2212002 and 2212020

Distribution

Distributed nationwide across the United States.

Related recalls

Same category