Class II — Vortex Surgical Inc.
| Recalling firm | Vortex Surgical, Inc. |
|---|---|
| Registered facility | Vortex Surgical, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 | Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25 |
| Quantity | 800 devices |
| Distribution | Worldwide - US Nationwide distribution in the states of OH, WA, MN, MI, IA and the country of Republic of Korea |
| Initiated | 2023-12-18 |
| Classified | 2024-02-01 |
| Terminated | 2024-04-04 |
| Recall number | Z-0970-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Vortex Surgical Inc. (Z-0970-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93725/
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