Vortex Surgical ACTU8 FORCEPS — Class II medical device recall Z-0970-2024
Terminated recall by Vortex Surgical Inc., reported 2024-02-07, distributed nationwide. Reason for the voluntary recall is residue was identified on the two forceps tips of a customer in Korea. The
| Recall number | Z-0970-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vortex Surgical Inc., Saint Charles, MO, United States |
| Recall initiated | 2023-12-18 |
| Classified | 2024-02-01 |
| Reported by FDA | 2024-02-07 |
| Terminated | 2024-04-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | KR |
| Quantity | 800 devices |
| UPC / GTIN / UDI-DI | 00810123481132 |
| Lot numbers | 2212002, 2212020 |
| Model numbers | VS0740.25 |
Product
Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0970-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.