Vortex Surgical Inc. Recalls Disposable Forceps and Cannulas Due to Potential Sterility Breach

What Happened

Vortex Surgical Inc. has initiated a voluntary Class II recall of various disposable forceps and cannulas. The recall was prompted by the discovery of potential voids in the seals of the Tyvek pouches used to package the instruments. A compromised sterile barrier creates a risk of bioburden contamination, which could lead to serious infection in patients during surgical procedures.

Which Products Are Affected

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

1. 23GA ACTU8 Forceps Adaptive (VS0740.23): Lot 2411009
2. 25GA ACTU8 Forceps Adaptive (VS0740.25): Lot 2410051
3. 25GA ACTU8 Forceps ILM (VS0744.25): Lots 2410021, 2410053, 2411006
4. 25GA ACTU8 Forceps ILM - Myopic (VS0744.25-35): Lot 2410059
5. 25GA ACTU8 Forceps Pro-Grip (VS0713.25): Lots 2410050, 2411011
6. 25GA ACTU8 Talon Forceps ILM (VS0752.25): Lot 2411003
7. 25GA ACTU8 Talon Forceps Pro-Grip (VS0751.25): Lot 2410060
8. 27GA ACTU8 Forceps ILM (VS0744.27): Lot 2410054
9. 23GA Soft Tip Cannula (VS0200.23): Lot 2410037
10. 23GA Soft Tip Cannula - 0.5mm (VS0205.23): Lot 2411032
11. 25GA Soft Tip Cannula (VS0200.25): Lot 2410039
12. 25GA Soft Tip Cannula - 0.5mm (VS0205.25): Lot 2410041
13. 25GA Soft Tip Cannula - 0.5mm - Bulk (VS0205.25B): Lots 2410042, 2411018
14. 25GA Soft Tip Cannula-Bulk (VS0200.25B): Lot 2410040
15. 27GA Soft Tip Cannula (VS0200.27): Lot 2412026

Distribution includes the following U.S. 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 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. notified affected customers via letter starting December 16, 2025. Healthcare facilities and distributors should immediately check their inventory for the catalog and lot numbers listed above. Affected products should be quarantined and handled according to the instructions provided in the firm’s notification letter. For further information, customers may 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 expose patients to harmful contaminants and increase the risk of post-operative infections.

Source

Recall information provided by the FDA. Recall Number: Z-1247-2026.