SQ40S Blood Transfusion Filter
FDA Recall #Z-1157-2026 — Class II — November 3, 2025
Product Description
SQ40S Blood Transfusion Filter
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.
Recalling Firm
GVS TM, Inc — Covina, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2,720 filters
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
Code Information
Product Number: SQ40S UDI-DI code: 10887691000666 Lot Number: 7536142
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated