Class II
Medical Device Recall: SQ40S Blood Transfusion Filter
GVS TM, Inc · November 3, 2025
Reason for Recall
Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.
Distribution
U.S.: ID, NV, SC, MO, TX, CO, MD, CA, VA, DC, PA, IL, OH, AZ, FL, OK, MN, KY, OR, NE, NC, LA, MS, MI, NY, GA, AL, MA
States Affected
AL, AZ, CA, CO, DC, FL, GA, ID, IL, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NV, NY, OH, OK, OR, PA, SC, TX, VA
Quantity Affected
2,720 filters
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1157-2026
Status: ongoing
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