# FDA recall Z-1256-2026

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

## Product

Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker

## 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-1256-2026
- **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-1256-2026

## Citation

> AI Analytics. FDA recall Z-1256-2026. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-1256-2026. Source: US FDA. Licensed CC0.

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