FDA Medical devices recall ·
SQ40S Blood Transfusion Filter recall
- Recall number
- Z-1157-2026
- Date
- (initiated November 3, 2025)
- Company / brand
- GVS TM, Inc
1630 W Industrial Park St, Covina, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2,720 filters
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
SQ40S Blood Transfusion Filter
Why was it recalled?
Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Product Number: SQ40S UDI-DI code: 10887691000666 Lot Number: 7536142
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
States: Alabama Arizona California Colorado District of Columbia Florida Georgia Idaho Illinois Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi North Carolina Nebraska Nevada New York Ohio Oklahoma Oregon Pennsylvania South Carolina Texas Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1157-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.