Vortex Surgical Recalls Backflush Devices Due to Potential Sterile Barrier Breach

What Happened

Vortex Surgical Inc. has initiated a voluntary recall of specific lots of its backflush surgical devices. The recall was triggered by the discovery of voids located in the seals of the Tyvek pouches used to package the instruments. A compromised sterile barrier presents a risk of bioburden contamination, which could lead to serious infections in patients during surgical procedures.

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:

• Vortex Surgical 25GA Backflush (Model VS0270.25)
  • Lot Number: 2411017
  • Pouch UDI: 810123480470
  • Box UDI: 810123480753
• Vortex Surgical 25GA Backflush Retractable (Model VS0275.27)
  • Lot Number: 2411016
  • Pouch UDI: 810123480517
  • Box UDI: 810123480791

Distribution in the United States included the following 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. notified affected customers via a formal letter initiated on December 16, 2025. Healthcare facilities and distributors should immediately check their inventory for the affected lot numbers (2411017 and 2411016). Any affected products should be quarantined and handled according to the instructions provided in the firm’s notification letter. For further information regarding returns or replacements, contact Vortex Surgical Inc. at their Saint Charles, MO headquarters.

Why This Matters

The integrity of a sterile barrier is critical for surgical instruments; any breach in the packaging seal can introduce bacteria or other contaminants, posing a significant health risk to patients undergoing invasive procedures.

Source

This information is based on an official recall notice from the FDA. Recall Number: Z-1255-2026.