Vortex Surgical Recalls I2 Injection Kits Over Potential Sterility Breach

What Happened

Vortex Surgical Inc. has initiated a voluntary recall of the Vortex Surgical I2 Injection Kit (Model VS0500). The recall was prompted by the discovery of potential voids in the seals of the Tyvek pouches used for the kits. These defects could compromise the sterile barrier of the medical device, potentially leading to bioburden contamination and subsequent patient infection.

Which Products Are Affected

The recall involves the following specific product details:

• Product Name: Vortex Surgical I2 Injection Kit, VS0500
• Recall Number: Z-1252-2026
• Lot Number: 2411012
• Pouch UDI: 810123480920
• Box UDI: 810123481330

A total of 14,789 units are affected, including 8,651 units distributed within the United States and 6,138 units distributed internationally. In the U.S., the product was distributed to 31 states: 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, and VA. International distribution included Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, and Vietnam.

What You Should Do

Vortex Surgical Inc. began notifying affected customers via a letter sent on December 16, 2025. Healthcare facilities and distributors should immediately check their inventory for Lot 2411012 and sequester any remaining units to prevent use. For information regarding returns or further instructions, contact Vortex Surgical Inc. at their headquarters: 4 Research Park Dr Ste 124, Saint Charles, MO 63304.

Why This Matters

The integrity of a sterile barrier is critical for medical devices used in surgical procedures. Voids in the packaging seal can allow microorganisms to contaminate the device, posing a serious risk of infection to patients during clinical use.

Source

This information is based on an official recall report from the FDA.