FDA Device recall Z-1157-2026
SQ40S Blood Transfusion Filter
- FDA Device
- Class II
- ongoing
- Published 2026-01-28
On 2026-01-28 the FDA classified a Class II recall of SQ40S Blood Transfusion Filter by Gvs Tm, citing due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1157-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-03 |
| Published | 2026-01-28 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Gvs Tm |
| Distribution | 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 |
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.
Identifiers
| code_info | Product Number: SQ40S UDI-DI code: 10887691000666 Lot Number: 7536142 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1157-2026%22
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