← FDA ENFORCEMENT
Z-1157-2026Class II

GVS TM, Inc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
GVS TM, Inc
Product type
Device
Status
Ongoing
Report date
2026-01-28
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
Firm state
CA
Product quantity
2,720 filters
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
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.

Product description

SQ40S Blood Transfusion Filter

Code / lot info

Product Number: SQ40S UDI-DI code: 10887691000666 Lot Number: 7536142

Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →