GVS TM, Inc recalled 2,720 SQ40S Blood Transfusion Filters on November 3, 2025. The recall follows concerns that the sterility assurance cannot be confirmed due to incomplete quality control processes. Healthcare providers and patients must stop using the device immediately.
Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GVS TM, Inc or your healthcare provider for instructions. Notification method: E-Mail
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The affected product is the SQ40S Blood Transfusion Filter with UDI-DI code 10887691000666 and Lot Number 7536142. These filters were distributed in various U.S. states including Texas, California, and New York. No price was specified.
The filters may not be sterile, as they were distributed before completing the necessary quality control release process. This poses a high risk of infection to patients receiving blood transfusions.
There are no reported injuries or deaths associated with this recall. The potential for harm remains due to the risk of infection.
Patients and healthcare providers should stop using the SQ40S Blood Transfusion Filter immediately. Contact GVS TM, Inc or your healthcare provider for further instructions.
For more information, email GVS TM, Inc. Visit the FDA website for additional details about the recall.
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