GVS TM, Inc: Device Recall
Recall #Z-1157-2026 · 11/03/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1157-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- GVS TM, Inc
- Status
- Ongoing
- Date Initiated
- 11/03/2025
- Location
- Covina, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,720 filters
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.
Product Description
SQ40S Blood Transfusion Filter
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
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.