# FDA recall Z-1247-2026

> **Vortex Surgical Inc.** · Class II · device recall initiated 2025-12-16.

## Product

Vortex Disposable Forceps and Cannula    1. 23GA ACTU8 Forceps Adaptive  VS0740.23    2. 25GA ACTU8 Forceps Adaptive  VS0740.25    3. 25GA ACTU8 Forceps ILM  VS0744.25    4. 25GA ACTU8 Forceps ILM -Myopic  VS0744.25-35    5. 25GA ACTU8 Forceps Pro-Grip  VS0713.25    6. 25GA ACTU8 Talon Forceps ILM  VS0752.25    7. 25GA ACTU8 Talon Forceps Pro-Grip  VS0751.25    8. 27GA ACTU8 Forceps ILM  VS0744.27    9. 23GA Soft Tip Cannula  VS0200.23    10. 23GA Soft Tip Cannula - 0.5mm  VS0205.23    11. 25GA Soft Tip Cannula  VS0200.25    12. 25GA Soft Tip Cannula - 0.5mm  VS0205.25    13. 25GA Soft Tip Cannula - 0.5mm - Bulk  VS0205.25B    14. 25GA Soft Tip Cannula-Bulk  VS0200.25B    15. 27GA Soft Tip Cannula  VS0200.27

## Reason for recall

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

## Distribution

Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.

## Key facts

- **Recall number:** Z-1247-2026
- **Recalling firm:** Vortex Surgical Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-16
- **Report date:** 2026-02-11

- **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-1247-2026

## Citation

> AI Analytics. FDA recall Z-1247-2026. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1247-2026. Source: US FDA. Licensed CC0.

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