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Recall Observatory FDA recall evidence

Device product

SQ40S Blood Transfusion Filter

Z-1157-2026

November 03, 2025

Class II

Product summary

Firm
GVS TM, Inc
Event
Event 98145
Status
Ongoing
Classification
Class II
Quantity
2,720 filters
Official record key
device-enforcement:Z-1157-2026

Official wording

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

Code information: Product Number: SQ40S UDI-DI code: 10887691000666 Lot Number: 7536142

Distribution pattern: 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

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterility assurance cannot be confirmed