SQ40S Blood Transfusion Filter — Class II medical device recall Z-1157-2026
Ongoing recall by GVS TM, Inc, reported 2026-01-28, distributed in AL, AZ, CA, CO, DC, FL, GA, ID…. Due to products being released for distribution prior to completion of the required quality control release pr
| Recall number | Z-1157-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GVS TM, Inc, Covina, CA, United States |
| Recall initiated | 2025-11-03 |
| Classified | 2026-01-22 |
| Reported by FDA | 2026-01-28 |
| Distributed | AL, AZ, CA, CO, DC, FL, GA, ID, IL, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NV, NY, OH, OK, OR, PA, SC, TX, VA |
| Quantity | 2,720 filters |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10887691000666 |
| Lot numbers | 7536142 |
Product
SQ40S Blood Transfusion Filter
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1157-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.