Vortex Surgical Inc. Recalls Oertli Laser Probes Due to Potential Sterility Breach

FDA Recalls high FDA · · Worldwide

Vortex Surgical Inc. has issued a voluntary recall for over 14,000 Oertli Laser Probes due to compromised packaging seals that could lead to patient infection.

What Happened

Vortex Surgical Inc. has initiated a voluntary recall of several models of Oertli Laser Probes. The company identified potential voids in the seals of the Tyvek pouches used for the devices. A compromised sterile barrier creates a risk of bioburden contamination, which could lead to serious infections in patients during surgical procedures.

Which Products Are Affected

The recall affects 14,789 units (8,651 in the U.S. and 6,138 internationally). The following Oertli Laser Probe models and specific lots are included:

  1. 23G Laser Probe OS4 Flex-Tip (VK401113): Lot 2410031; Pouch UDI 810123483716; Box UDI 810123483792
  2. 23G Laser Probe OS4 Illuminated Flex-Tip (VK401213): Lot 2410034; Pouch UDI 810123483730; Box UDI 810123483815
  3. 23G Laser Probe OS4 Intuitive Extendable (VK401323): Lot 2410033; Pouch UDI 810123483761; Box UDI 810123483846
  4. 25G Laser Probe OS4 Flex-Tip (VK401115): Lots 2410032, 2410058, 2411022; Pouch UDI 810123483723; Box UDI 810123483808
  5. 25G Laser Probe OS4 Illuminated Flex-Tip (VK401215): Lot 2410035; Pouch UDI 810123483747; Box UDI 810123483822
  6. 25G Laser Probe OS4 Intuitive Extendable (VK401325): Lot 2412025; Pouch UDI 810123483778; Box UDI 810123483853
  7. 27G Laser Probe OS4 Intuitive Extendable (VK401327): Lot 2411021; Pouch UDI 810123483785; Box UDI 810123483860

Distribution includes nationwide U.S. shipping to 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, as well as international distribution to over 20 countries.

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 catalog numbers 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 the patient.

Source

Recall information provided by the FDA under Recall Number Z-1246-2026.

Source: FDA Official Notice

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