Vortex Surgical I2 Injection Kit, VS0500
Reported: February 11, 2026 Initiated: December 16, 2025 #Z-1252-2026
Product Description
Vortex Surgical I2 Injection Kit, VS0500
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.
Details
- Recalling Firm
- Vortex Surgical Inc.
- Units Affected
- 14,789 (8651 US; 6138 OUS)
- 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.
- Location
- Saint Charles, MO
Frequently Asked Questions
What product was recalled? ▼
Vortex Surgical I2 Injection Kit, VS0500. Recalled by Vortex Surgical Inc.. Units affected: 14,789 (8651 US; 6138 OUS).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 11, 2026. Severity: Moderate. Recall number: Z-1252-2026.
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