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 Vortex Surgical TID Pharos Illuminated Depressor is a medical device used in surgical settings to provide illumination during procedures. Healthcare providers purchase it for its functionality in enhancing visibility during operations.
The specific hazard has not been disclosed, but the Class II recall indicates a potential for adverse health effects. Users should cease use immediately to mitigate risks.
This recall is not part of a broader industry pattern.
The recall may cause inconvenience for healthcare providers relying on this device for procedures. The high hazard level raises significant safety concerns for patient care.
Model number can typically be found on the device packaging or documentation.
Expect a response regarding refunds or replacements within 4-6 weeks after contacting the manufacturer.
Keep records of all correspondence, including emails and letters from the manufacturer. Document the date of purchase and any health issues experienced.
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.
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