Recall Z-1157-2026 ยท CAK Microfilter, Blood Transfusion
GVS TM, Inc
SQ40S Blood Transfusion Filter
| Date | Jan 22, 2026 (initiated Nov 3, 2025) |
| Status | Open, Classified |
| Reason | Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed. |
| Root cause | Process control |
| Action | On 11/03/2025, the firm sent via email a "GVS TM Inc Customer Statement" informing customers that GVS TM Inc discovered that some of the products in the affected lot may have been damaged during the transportation process. To avoid any potential risk this damage may pose to the downstream user, the firm is requesting return of the affected products. On 11/18/2025, the firm sent via email a "GVS TM Inc Product Recall Statements" informing customers that the products were distributed before completion of the required quality control release process, including final review of sterilization docu |
| Quantity | 2,720 filters |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960993 | PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST) Pall Biomedical Products Co., Apr 22, 1996 |