Vortex Surgical Inc. recalls Vortex Surgical I2 Injection Kit
- Recalling company
- Vortex Surgical Inc.
- Product
- Vortex Surgical I2 Injection Kit, VS0500
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Dec 16, 2025
- Reported
- Feb 11, 2026
- 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.
- Status
- Ongoing
- Quantity
- 14,789 (8651 US; 6138 OUS)
- Lot / codes
- Pouch UDI 810123480920 Box UDI 810123481330 Lot 2411012
- Company location
- Saint Charles, MO
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1252-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1252-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.