Recall archive / FDA device enforcement
SQ40S Blood Transfusion Filter — FDA record Z-1157-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 3, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- GVS TM, Inc
- Quantity
- 2,720 filters
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1157-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Product Number: SQ40S UDI-DI code: 10887691000666 Lot Number: 7536142 |
Match all identifying details in the current notice. A brand name alone is not enough.
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jan 28, 2026
- Recall initiation date
- Nov 3, 2025
- Center classification date
- Jan 22, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.