Recall Z-1245-2026 ยท HQB Photocoagulator And Accessories
Vortex Surgical Inc.
Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. 25GA Laser Probe Flex-Tip Cat No. VS0130.25 4. 25GA Laser Probe Illuminated Curved Cat No. VS0125.25B 5. 25GA Laser Probe MaxReach Cat No. VS0140.25 6. 25GA Laser Probe Straight Cat No. VS0110.25
| Date | Feb 4, 2026 (initiated Dec 16, 2025) |
| Status | Open, Classified |
| Reason | There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection. |
| Root cause | Employee error |
| Action | On December 16, 2025, the firm began notifying customers via "URGENT: MEDICAL DEVICE RECALL" letters. Customers were instructed to discontinue use of affected product and to return product for Vortex Surgical to evaluate the seals; use UPS account 23623Y to ship unused products to Vortex Surgical Inc for replacement or refund at: Attn: Andrew Ritts Recall Tyvek Seal, Vortex Surgical Inc., 4 Research Park Dr., Suite 124, St. Charles, MO 63304; complete and return the Acknowledgement and Receipt Form via mail or email to: ARitts@VortexSurgical.com. Actions have been implemented to improve train |
| Quantity | 14,789 (8651 US; 6138 OUS) |
| Distribution | Worldwide Distribution: US (nationwide) to states of: 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, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220263 | Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgica Vortex Surgical, Inc., Nov 3, 2022 |