Food, drugs, devices › Vortex Surgical Inc.
Device recall: Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
FDA enforcement event 93725 is a device recall by Vortex Surgical Inc. of Saint Charles, MO, initiated 18 Dec 2023 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Terminated, terminated 4 Apr 2024. Initiation: voluntary: firm initiated. Vortex Surgical Inc. has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Vortex Surgical Inc., Saint Charles, MO.
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."
Distribution
"Worldwide - US Nationwide distribution in the states of OH, WA, MN, MI, IA and the country of Republic of Korea"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0970-2024 | Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25 | 800 devices | Class II | Terminated | 7 Feb 2024 |
Context
Other enforcement events for Vortex Surgical Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 16 Dec 2025 | Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD | Device | Class II | 13 |
| 19 Nov 2025 | Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25; | Device | Class II | 1 |
All 3 events for Vortex Surgical Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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 does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide - US Nationwide distribution in the states of OH, WA, MN, MI, IA and the country of Republic of Korea"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 4 Apr 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.