FDA recall Z-1256-2026

Vortex Surgical Inc. · Class II · device

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1256-2026