FDA Medical devices recall ·
Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker recall
- Recall number
- Z-1256-2026
- Date
- (initiated December 16, 2025)
- Company / brand
- Vortex Surgical Inc.
4 Research Park Dr Ste 124, Saint Charles, MO, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 14,789 (8651 US; 6138 OUS)
- Hazard tags
- Sterility Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Pouch UDI 810123483655 Box UDI 810123483662 Lot 2408035
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.
States: Alabama Arkansas Arizona California Connecticut Florida Hawaii Iowa Illinois Indiana Kentucky Massachusetts Michigan Minnesota Mississippi North Carolina Nebraska New Jersey New Mexico New York Ohio Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Virginia Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1256-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.