Z-1157-2026 Class II Ongoing
FDA device recall Z-1157-2026 was initiated by GVS TM, Inc on Nov 3, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 2,720 filters.
Recall details
- Product Type
- Devices
- Report Date
- Jan 28, 2026
- Initiation Date
- Nov 3, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,720 filters
Product description
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.
Distribution pattern
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
Code information
Product Number: SQ40S UDI-DI code: 10887691000666 Lot Number: 7536142
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1157-2026
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026