Vortex Surgical recalled 14,789 units of the TID Pharos Illuminated Depressor on December 16, 2025. The recall affects 8,651 units in the U.S. and 6,138 units internationally. Patients and healthcare providers should cease use immediately due to a high hazard level.
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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 recalled product is the Vortex Surgical TID Pharos Illuminated Depressor, model VS0801B. It was distributed worldwide, with significant distribution in the U.S. states including California, Florida, and New York. The units were sold in various international markets including Australia, Germany, and Japan.
The exact nature of the hazard has not been disclosed, but it is classified as a Class II recall, indicating a potential for serious injury or adverse health consequences. The recall was initiated due to concerns that could compromise patient safety.
No specific incidents have been reported in connection with this recall. The high hazard classification suggests a significant risk that necessitated the recall.
Patients and healthcare providers should stop using the Illuminated Depressor immediately. Follow the recall instructions provided by Vortex Surgical and contact your healthcare provider for further guidance.
For further information, contact Vortex Surgical Inc. directly or visit their website. Additional details can be found at the FDA recall page.
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