Vortex Surgical Inc.: Device Recall
Recall #Z-1255-2026 · 12/16/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1255-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Vortex Surgical Inc.
- Status
- Ongoing
- Date Initiated
- 12/16/2025
- Location
- Saint Charles, MO, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,789 (8651 US; 6138 OUS)
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.
Product Description
Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27
Distribution Pattern
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.
Other Recalls by Vortex Surgical Inc.
- Class II: Risk 12/16/2025
- Class II: Risk 12/16/2025
- Class II: Risk 12/16/2025
- Class II: Risk 12/16/2025
- Class II: Risk 12/16/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.