CLASS II Device recall · Reported 7 Feb 2024 · FDA Enforcement Report

Actu8 Forceps, Adaptive recalled by Vortex Surgical

Vortex Surgical is recalling Actu8 Forceps, Adaptive, distributed nationwide in the US. The recall was initiated on 18 Dec 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 00810123481132, Lot Numbers 2212002 and 2212020

Quantity recalled800 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0970-2024
FDA event ID: 93725
Recalling firm: Vortex Surgical, Saint Charles, MO
Classification: Class II
Status: Terminated
Recall initiated: 18 Dec 2023
FDA classified: 1 Feb 2024
Reported: 7 Feb 2024
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

18 Dec 2023	Recall initiated by company
1 Feb 2024	Classified by FDA	+45 days
7 Feb 2024	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Iowa Michigan Minnesota Washington

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI/DI 00810123481132, Lot Numbers 2212002 and 2212020

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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