Vortex Surgical Inc. Recalls Convenience Kits Over Potential Sterility Breach

What Happened

Vortex Surgical Inc. has initiated a voluntary recall of several models of its convenience kits. The recall was prompted by the discovery of potential voids in the seals of the Tyvek pouches used to package the devices. A compromised sterile barrier presents a risk of bioburden contamination, which could lead to serious infections in patients.

Which Products Are Affected

The recall affects a total of 14,789 units (8,651 in the United States and 6,138 internationally). The following products and lots are included:

1. 25GA Convenience Kit - FNX (VS0644.25-FNX)

   • Lot: 2410055
   • Pouch UDI: 810123482917
   • Box UDI: 810123482924

2. 25GA Convenience Kit - FXX (VS0644.25-FXX)

   • Lot: 2411028
   • Pouch UDI: 810123482429
   • Box UDI: 810123482443

3. 25GA Convenience Kit - XES (VS0644.25-XES)

   • Lot: 2410057
   • Pouch UDI: 810123482412
   • Box UDI: 810123482436

Geographic Distribution: In the United States, the products were distributed to 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Washington, Wisconsin, and Virginia.

International distribution includes 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 letter on December 16, 2025. Healthcare providers and facilities should immediately check their inventory for the affected lot numbers and UDIs listed above. Affected products should be quarantined and handled according to the instructions provided in the firm’s notification letter. For further information, the recalling firm is located at 4 Research Park Dr Ste 124, Saint Charles, MO 63304.

Why This Matters

The integrity of a medical device’s sterile barrier is critical for patient safety. Voids in the packaging seals can allow contaminants to enter the kit, significantly increasing the risk of post-operative infections for patients undergoing procedures with these devices.

Source

Information provided by the U.S. Food and Drug Administration (FDA). Recall Number: Z-1249-2026.