Vortex Surgical recalled 14,789 single-use vitrectomy lenses on December 16, 2025. The recall affects models with potential seal voids that could lead to bioburden contamination. Patients and healthcare providers must stop using these devices immediately.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Vortex Surgical Inc. or your healthcare provider for instructions. Notification method: Letter
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The recall includes two models: Flat Vitrectomy Lens, Catalog VFD and Volk Magnifying Lens, Catalog VMD. The affected products were distributed in the U.S. and internationally, with specific lots identified for recall.
Voids in the seal of Tyvek pouches may compromise the sterile barrier of the lenses. This could lead to contamination and increase the risk of infection during medical procedures.
No specific incidents, injuries, or deaths have been reported in connection with this recall. The risk remains significant due to the potential for infection.
Stop using the affected lenses immediately. Contact Vortex Surgical Inc. or your healthcare provider for further instructions and follow the recall guidelines provided.
For more information, contact Vortex Surgical Inc. or visit the FDA recall website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1244-2026.
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