Vortex Surgical Recalls Laser Probes Due to Potential Sterile Barrier Breach

FDA Recalls high FDA · · Worldwide

Vortex Surgical Inc. has initiated a voluntary recall of over 14,000 laser probes because voids in the packaging seals could lead to contamination and infection.

What Happened

Vortex Surgical Inc. has initiated a voluntary recall of several models of laser probes due to a manufacturing defect. According to the FDA, there may be voids located 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 patient infections during medical 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 lot numbers are included:

  • 23GA Laser Probe Curved: Cat No. VS0120.23; Lot 2411027; Pouch UDI 810123480036; Box UDI 810123480180
  • 25GA Laser Probe Curved: Cat No. VS0120.25; Lot 2411026; Pouch UDI 810123480043; Box UDI 810123480197
  • 25GA Laser Probe Flex-Tip: Cat No. VS0130.25; Lots 2411024, 2411031; Pouch UDI 810123480111; Box UDI 810123480265
  • 25GA Laser Probe Illuminated Curved: Cat No. VS0125.25B; Lot 2411025; Pouch UDI 810123480098; Box UDI 810123480241
  • 25GA Laser Probe MaxReach: Cat No. VS0140.25; Lots 2410029, 2411023; Pouch UDI 810123480135; Box UDI 810123480289
  • 25GA Laser Probe Straight: Cat No. VS0110.25; Lot 2411030; Pouch UDI 810123480012; Box UDI 810123480166

Distribution in the U.S. includes 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.

What You Should Do

Vortex Surgical Inc. notified affected customers via letter starting in December 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, 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 high risk of post-operative infection to patients.

Source

This information is based on an official recall notice from the FDA under recall number Z-1245-2026.

Source: FDA Official Notice

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