Class II — GVS TM, Inc
| Recalling firm | GVS TM, Inc. |
|---|---|
| Registered facility | GVS TM, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed. |
| Product | SQ40S Blood Transfusion Filter |
| 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 |
| Initiated | 2025-11-03 |
| Classified | 2026-01-22 |
| Recall number | Z-1157-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — GVS TM, Inc (Z-1157-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98145/
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