FDA DevicesClass II
SQ40S Blood Transfusion Filter
Published: January 28, 2026Recall ID: Z-1157-2026Category: devicesCountry: US
Reason for Recall / Hazard
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 & Identification
SQ40S Blood Transfusion Filter
Additional Source Details
| Field | Value |
|---|---|
| City | Covina |
| State | CA |
| Event id | 98145 |
| Address 1 | 1630 W Industrial Park St |
| Code info | Product Number: SQ40S UDI-DI code: 10887691000666 Lot Number: 7536142 |
| Postal code | 91722-3419 |
| Report date | 20260128 |
| Product type | Devices |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251103 |
| Initial firm notification | |
| Center classification date | 20260122 |
Overview
- Recalling FirmGVS TM, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionU.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