GVS TM, Inc recalls SQ40S Blood Transfusion Filter

Recall date

November 3, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1157-2026

FDA classification

Class II

Brand / firm

GVS TM, Inc

Sold / distributed

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

Why it was recalled

Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SQ40S Blood Transfusion Filter