Recall Z-1157-2026— GVS TM, Inc

Name: FDA recall Z-1157-2026
Creator: U.S. Food and Drug Administration
Published: 2025-11-03

Class II · Ongoing

Class II FDA medical device recall by GVS TM, Inc, initiated 2025-11-03. It names one FDA 510(k) clearance: K960993. Product: SQ40S Blood Transfusion Filter. Reason: 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
Classification: Class II
Status: Ongoing
Initiated: 2025-11-03
Firm location: Covina, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K960993 — PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)Pall Biomedical Products Co.·cleared 1996-04-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.