# FDA recall Z-0970-2024

> **Vortex Surgical Inc.** · Class II · device recall initiated 2023-12-18.

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-0970-2024
- **Recalling firm:** Vortex Surgical Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2023-12-18
- **Report date:** 2024-02-07
- **Termination date:** 2024-04-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Charles, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0970-2024

## Citation

> AI Analytics. FDA recall Z-0970-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0970-2024. Source: US FDA. Licensed CC0.

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