Vortex Surgical Recalls 25GA Subretinal Injection Cannula Due to Potential Sterility Breach

What Happened

Vortex Surgical Inc. has initiated a voluntary recall of its 25GA Subretinal Injection Cannula. The recall was prompted by the discovery of 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 undergoing subretinal procedures.

Which Products Are Affected

The recall affects the following specific medical device:

• Product Name: 25GA Subretinal Injection Cannula
• Model Number: VS0220.25
• Lot Number: 2410043
• Pouch UDI: 810123480418
• Box UDI: 810123480692

A total of 14,789 units are involved in this recall (8,651 in the U.S. and 6,138 internationally). The product was distributed nationwide across 31 U.S. states and internationally to countries including Australia, China, France, Germany, India, Japan, and the United Kingdom.

What You Should Do

Vortex Surgical Inc. notified affected customers via a formal letter. Healthcare providers and facilities are advised to immediately inspect their inventory for the affected lot number (2410043). Any identified units should be quarantined and not used in clinical settings. For information regarding returns or further instructions, contact Vortex Surgical Inc. at 4 Research Park Dr Ste 124, Saint Charles, MO 63304.

Why This Matters

Maintaining a sterile barrier is critical for surgical instruments used in subretinal injections. A breach in this barrier can introduce contaminants directly into the eye, posing a high risk of severe infection and potential vision-threatening complications.

Source

This information is provided by the FDA under recall number Z-1248-2026.